[This Transcript is Unedited]

NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS

NATIONAL HEALTH INFORMATION INFRASTRUCTURE WORK GROUP

2004 CORNERSTONES FOR ELECTRONIC HEALTH CARE

July 23, 2004

Washington Convention Center
801 Mount Vernon Place, NW
Washington, D.C.

Proceedings By:
CASET Associates, Ltd.
10201 Lee Highway, Suite 160
Fairfax, Virginia 22030
(703)352-0091

List of Participants:

  • John R. Lumpkin, M.D., Chair
  • Jeffrey S. Blair, MBA
  • Simon P. Cohn, M.D.
  • John P. Houston, J.D.
  • Stan M. Huff, M.D.
  • C. Eugene Steuerle, Ph.D
  • Kevin C. Vigilante, M.D.
  • Mary Jo Deering, Ph.D
  • Eduardo Ortiz, M.D.
  • Anna Poker
  • Steven J. Steindel, Ph.D
  • William A. Yasnoff, M.D.
  • Michelle Williamson
  • Justine Carr, M.D.
  • Judy Warren
  • Marjorie Greenberg, M.D.

TABLE OF CONTENTS


P R O C E E D I N G S (8:10 A.M.)

Agenda Item: Welcome

DR. LUMPKIN: Good morning. My name is John Lumpkin. I am senior vice
president of The Robert Wood Johnson Foundation and Chair of The National
Committee for Vital and Health Statistics and also Chair of the Work Group of
the National Health Information Infrastructure. A couple of housekeeping
announcements and then we will go straight into introductions of the Committee.

(Housekeeping announcements).

Let me do introductions and then we will go through the agenda and talk a
little bit about how it is going to work and then I will tell you why you are
here with the Committee.

(Introductions.)

DR. LUMPKIN: Welcome. The structure of the conference has been such that
you have had two days of varying kinds of activities. Wednesday, with the very
important announcements from the Secretary and other members

of HHS and the other federal agencies that are partners. Yesterday a lot of
you did a lot of work in the breakout groups, and we are bringing those back to
the work of this particular subcommittee that has been involved with the
National Health Information Infrastructure.

The National Committee on Vital and Health Statistics is the advisory
committee designed by Congress to advise the Secretary in issues related to
health information policy. I think the reason why we are all here can be best
summed up in the work of Albert Dunn, who just a few years prior to the
formation of the committee described what we are all about. He said that each
person in the world creates a book of life. This book starts with birth and
ends with death. Its pages are made up of the records of the principal events
in life. Linkage is the name that is given to the process of assembling these
pages of this book of life into a volume. Thinking backward, each person can
remember the important pages of the book, even though he may have forgotten
some or all of the words, but no one would read a novel if the pages were not
assembled.

Our goal, the goal of the National Health Information Infrastructure, is to
create that book of life, so that when you have a health encounter, those pages
are available for the clinicians who are making decisions, and therefore,
individuals that those pages are available, for them to make their own health
decisions. This has been much of what has been discussed over the last few
weeks.

The National Committee on Vital and Health Statistics serves as a statutory
advisory body to the Secretary of Health and Human Services in areas of health
data, health statistics and national health information policy. We provide
advice and assistance to the Department, and it serves as a forum for
interaction with those interested private sector groups in a variety of key
health issues. We were actively involved in developing the recommendations to
the Department in relationship to the HIPAA standards. Regardless of whether
you like them or don’t like them, without HIPAA we wouldn’t be here.

in that role, we have enabled the ability to have hearings. I have to
admit, this may be the largest hearing that we have had, but we have had the
ability to have hearings so that the is that you are most concerned about
immediately come into the Department in a structure in which the Department can
respond and amend those. So much of our work together in developing the
foundation that has brought us here has been based upon that interaction
between the private sector and the Department through the auspices of the
NCVHS.

We were formed in 1949. We provide the bridge between the government and
the health industry. Initially we were a standards development organization,
working to develop ICD in its various iterations, working on the national
level. Now, since the formation of HIPAA, our role has been to help the
Department identify those standards that ought to be adopted. Early on those
standards were adopted in rule, and now based on our recommendations, they were
adopted through the consolidated health informatics as best practices by the
Department.

The committee is composed of 18 individual from the private sector who have
distinguished themselves, mostly, — I can speak for the rest of the committee,
I’m not sure about myself — as researchers, educators and practitioners in
such fields as population-based public health, epidemiology, health information
systems, health data standards, health services and privacy and
confidentiality. We have quite spirited discussions. Most of our work has
evolved out of many days of hearings. As Simon Cohn, who is also the chair of
the Subcommittee on Standards and Security, and Jeff Blair have taken the lead
on the e-prescribing standards can tell you, it requires a lot of work, and we
do want to make sure that we hear from everybody.

Sixteen of our members are appointed by the Secretary, and two of the
members are appointed, one by the Speaker of the House and the other by the
leader of the Senate. The members of the committee are on your list here. I
think they are also available on the website. I won’t read all of the
individuals. You heard introductions this morning.

The structure of the NCVHS. We have a full committee that meets roughly
quarterly. Our subcommittees, the Subcommittee on Standards and Security, those
are the ones who work through the HIPAA standards, work through the adoption of
the consolidated health informatics standards and making recommendations to the
Department, as well as currently working long hours on the e-prescribing
standards. The Subcommittee on Privacy and Confidentiality, which is engaged in
making recommendations. We made the first recommendations to the Department on
the HIPAA privacy rule. All the good stuff we recommended, and probably some of
the bad stuff, too. Finally, the Subcommittee on Populations, which is making
the connections between medical practice and population health.

Our major recommendation in regards to the National Health Information
Infrastructure was a report on information for health. It was given on November
15, 2001. It was based upon an earlier letter to the Secretary in 1998, which
was signed by Don Dettmer, calling for the formation of the National Health
Information Infrastructure.

As we issued that report, we noted that there were three important
dimensions, not that these were physical things, but if the National Health
Information Infrastructure was going to work, it had to work from the
perspective of the health care provider, the personal health dimension for each
individual who is receiving health care, and also for the population health
dimension.

Our role throughout this process and through the development of the
National Health Information Infrastructure has been and will be to facilitate
public-private dialogue, which we will do today, provide expert advice on
specific areas, provide general oversight, and support progress through the
national health privacy legislation. This we believe has been an important
role.

The National Health Information Infrastructure work group, which is the one
that we are here today, our charge has been to first develop the vision for the
National Health Information Infrastructure, and then following that, to monitor
the progress of implementation and to provide a space for people to come in to
give comments, and for us to advise the Department.

What we are going to do today as we follow through on that role is take
testimony. One other thing I forgot to tell you. As in most of the meetings of
the National Committee on Vital and Health Statistics, we are going live over
the Internet. So if you are here and you tell your boss that you are on the
job, be careful about speaking on the microphone. Just one word of caution.

What we are going to do today on the agenda, we are going to take testimony
from the first four groups, that is, Personal Health, Governance, Incentives,
Standards and Architecture. After we take those four presentations from the
work group of ten minutes each, we will then have time for questions and
comments. We will take questions and comments from the work group and from
those in the audience, time available. We will then proceed after the break to
take testimony on confidentiality, ethics, privacy and access and measuring
progress, population health and clinical research.

We will again take questions and comments.

When you give your questions and comments, please come to the microphone.
There are six microphones scattered throughout, and I will call on them in
order.

We will have lunch. Lunch is on your own, and after that the committee will
reconvene, and we will hear a short presentation from the Connecting for Health
to the work group, and then we will have work group discussion on where we go
from here, what we have learned, and what are the next steps for us as a
committee, and all of you are invited to attend that session.

So why don’t we start with the presentations. There is an interpreter for
those who are hearing impaired in the front to the left. Why don’t we start off
with the first group, which is on personal health. The developers of the report
are Mark Boutin and Suzanne Bakken, and Mark will be giving the report, if he
will come forward.

Testimony and Recommendations

Agenda Item: Personal Health

MR. BOUTIN: Good morning. Before I begin, I would like to thank the
President, the Secretary, Dr. Brailer and this committee for the opportunity to
participate in this conference and to present before you today. I would also
like to thank our topic leaders, our experts, facilitators, but most especially
the participants in this work group yesterday. Their enthusiasm and passion was
extraordinary, and we really appreciate the work they put into this yesterday.

Our group developed six recommendations which I will go through now. The
first recommendation was that Dr. Brailer’s office should accelerate momentum
toward national scale adoption of personal health records. To that end, we
identified several specific activities that we feel ought to be accomplished
during the first year.

The first issue is to reconvene the stakeholders within 60 days. We feel it
is important that we bring these groups together to continue the exciting
dialogue that we have all experienced over the last several days. In addition,
foster basic consumer research within the next six months. It is critical that
we inspire patients, families and consumers with the many aspects of personal
health records that are important to them. We need to identify which of those
aspects are going to move them into early adoption and continued use and
integration of personal health records into their daily lives.

In addition, develop messaging and a branding strategy. Current research
shows that the general public is largely unaware of the potential value of
personal health records. We feel it is important that we frame this issue in
the minds of the general public and make this an important issue for them to
manage their own health care.

In addition, implement an education strategy for both patients, consumers
and other stakeholders. This piece is critical. We need to have a technical
assistance capacity throughout the country so that we can accommodate what is
largely going to be a major paradigm shift in how we all access and manage our
health care.

Personal health records are largely about individual health and managing
that individual health. While it may be obvious, we wanted to underscore and
emphasize for the committee that patients, consumers, families be involved and
represented on all policy committees and advisory boards. We think it is
critical that they be at the table.

As I am sure you will hear from all the groups, the personal health records
group identified standards, particularly functional and data standards. We feel
that Brailer’s office should insure the creation of a core functional standard
for personal health records within 12 months to enable subsequent
certification. In addition, we feel that Brailer’s office should collaborate
with a consolidated health informatics group with identifying data standards
needed to support personal health records within six months, and commit to the
development and/or adoption and implementation of those standards within 12
months. Very ambitious, but we think this is a critical step to move forward.

Our next recommendation was not without controversy: Establish an approach
to uniquely identifying patients. The wording of that recommendation was
carefully crafted. I see a few people smiling, so you already understand the
issues. What I want to emphasize however is that the controversy was around how
we accomplish this recommendation. Our group felt very strongly, and there was
a great consensus, that this was an issue that was important, and it was
necessary for us to achieve the full benefits available under personal health
records and the technology available.

We also identified a number of demonstration projects that we thought would
be critical to moving this process forward. First, we would like to see a CMS
pilot to establish beneficiary access to free personal health records,
including standard intake, history, health summary forms.

In addition, we would like to see a privately funded demonstration project
or projects related to personal health records, support of chronic medical
conditions and lifestyle management issues. In addition, we would like to see
personal health record pilot projects that deal with broad applicability to
specific issues like medications, prescription drugs, immunizations.

Our last recommendation deals expressly with incentives. We would like to
ask the Secretary of Health and Human Services to present to Congress by
January 2005 legislation that would address tax incentives to encourage people
to purchase personal health records. The incentive piece is critical, and we
feel that this would be a critical first step to moving this issue forward.

I’d like to again thank the President, the Secretary, Dr. Brailer and this
committee for allowing us to participate in this, offer our recommendations,
and as stated earlier, to help in the development of this electronic book of
life that was mentioned earlier.

Thank you very much.

DR. LUMPKIN: We are going to take questions and answers at the end of the
first group presentations. So we will move to governance. That is Laura Adams
and Richard Marks, and they are going to do a joint presentation.

Agenda Item: Governance

MS. ADAMS: Good morning. My name is Laura Adams. I am the President and CEO
of the Rhode Island Quality Institute. We too want to thank the committee for
the ability to prepare and offer this report today from our governance group.
We too had a passionate and energized group, who had a lot to say about this
particular topic. We hope that we will be able to deliver that message briefly,
but yet, it is profound as well.

We delivered our recommendations in two categories. The first category I
will speak to, and that category is the LHII, or what is referred to in Dr.
Brailer’s report as the RHIO, the regional health information organization,
governance as it relates to the organizational and technological infrastructure
of the NHII. This was a concern for many of the people in our group that were
trying to think about how to organize and set forth the local health
information infrastructures.

Our recommendations were that DHHS should first define the governing and
functional relationships of the NHII to the LHII, exactly what does it mean to
be an LHII; does that provide some sort of advantage, is there some sort of
guideline characteristics that would allow one to call oneself an LHII, what
does it mean to be one.

The second recommendation is furnish the minimal functions and
technological interoperability standards of the NHII and the LHIIs. For many in
our group that are preparing to move forward with this, the real question and
the real concern was, if we begin to move forward, how will we be sure that we
are moving in alignment with the National Health Information Infrastructure.
There was grave concern that they may be taking on an approach, taking on a
function, not understanding what the vision is coming from the National Health
Information Infrastructure. So that was to help give guidance to those groups
as they are making very important decisions. I would have to say that those
decisions are being made now for many of those organizations. So we would like
to see this one happen as soon as possible.

The third was to establish a set of guiding principles for LHII governance.
These things insure appropriate community representation; would that be a
guideline that would come out of the national organization that would tell us
what these ought to look like in principle, give us guidance around things such
as the strategy component of this; are there certain organizations that ought
to be represented, are there certain policies that ought to be reflected in the
LHIIs in order to be consistent with the philosophy and direction of the
national approach. Also, the differentiation between that and the tactical
approach, that level where we would be looking at the administration or the
organization and the actual execution of this work; are there certain
guidelines that you could give us around that to make sure that we are moving
in concert with this, given that the goal overall is to eventually link all of
us in many ways, shapes or forms.

MR. MARKS: Good morning. I am Richard Marks, President of Patient Command,
Inc. Our second category of recommendations falls into the basket of resources.
Our recommendations are that DHHS should promptly perform the four tasks that
you see on the screen. Of course, they are interrelated.

The first is a resource center for LHIIs and people who are in their
communities, looking to establish LHIIs so that they can accelerate and
catapult the effort. I want to focus on the last two items in the
parenthetical. Actual objective case studies were thought by the group to be
very important. That includes case studies to be positive, as David Brailer has
encouraged us to be, of successes, but also studies of failures and of
difficulties, because that will help people who are setting these organizations
up to avoid repeating the mistakes of others.

Then an interactive portal, which can be used for a national dialogue among
people who are engaged in creating LHIIs, an information resource, but
something far more than that.

The second item warms the heart of the lawyers. It is establishing a
database of legal analyses. There is a whole series of fundamental analyses
that are going to be common to many of these efforts. This isn’t intended to
presage a cookie cutter approach, but it is intended to give lawyers around the
country and their clients who are getting into these issues a head start so
that they don’t have to constantly re-invent the fundamental research and
analysis that needs to be done.

It is I suppose unsurprising that you would see the next item, a program of
planning grants. I don’t want to dwell on this, because I know that this is
already in progress, but the committee felt very strongly that these were
necessary. There are issues of formation and selection of trusted conveners, of
stakeholders and a national resource here would be very helpful.

The last item on the list, the critical analysis of initiatives of course
relates to the notion of actual objective case studies, but it is somewhat
different. The group felt strongly that a series of abstract analyses of models
would be helpful to people as they began to work in their communities or their
regions to create these local and regional organizations.

That is our report.

DR. LUMPKIN: Thank you very much. The next one is on incentives, and Susan
Christiansen will be making that report.

Agenda Item: Incentives

MS. CHRISTIANSEN: Good morning. I am Susan Christiansen. I am a director in
Bearing Points Health Care Practice. I am going to present the regulations from
the incentives group. We had roughly 150 people in two groups, and widely
divergent perspectives. So it was a very engaging and deep conversation in many
ways. We produced a very different set of recommendations out of each group. I
want to recognize the people, Francois, Karen, Ann and Mark, for their skillful
preparation and management of the whole process to bring these recommendations
to you. It was a challenge.

This is one of the most challenging aspects of moving toward our national
system. Our recommendations fall into three broad categories. We tried to make
them meet the requirements of being actionable, realistic and clear. A lot of
people had wonderful ideas about financing this, but we tried to keep focused.

The three categories are policy, upfront funding and private payor
compensation. They are primarily financial incentives, however other related
issues continued to surface during the discussions, so we included them as
well, because people felt very strongly about them.

First, in policy recommendations, we divided them into responsibilities for
Dr. Brailer to do in his spare time and some things for Congress to do. First,
expand the AHRQ’s HIT resource center to include support for all stakeholders
with information about certification standards and assessment tools for product
implementation, best practices, product scorecard and funding sources. We are
starting to see some themes in all of these recommendations. I think there will
be some commonality across, and we will have some steps to move forward
quickly.

Second, create a consumer and provider education campaign on the benefits
of EHR adoption, and also create a public reporting system to highlight
physicians who have adopted and are using EHRs for consumers who want to use
them. Establish a certification process for EHRs that clinicians can use when
purchasing. Create an interoperability standard funded by all appropriate
parties. Interoperability standards should be an essential part of the EHR
certification processes. The CCR standards should be incorporated into
standards. Finally, we asked the coordinator to work with Congress to include
safe harbor legislation to protect providers and payors, and I probably want to
add vendors, there are some issues around vendors, too, in NHII activities, for
example, clarify the stark and anti-kickback rules and establish some safe
harbors in litigation for liability.

Congressional recommendations. These would involve Congress and CMS,
because some of this can be done by regulation. First of all, reform the
Medicare reimbursement system for physicians, including repeal of the
sustainable growth rate methodology. The new system should include payments for
care management, disease management, data sharing, publishing, subscribing,
performance, accountability and quality. In this way, they would reflect and
encourage the practices that are enabled by the new technologies.

Upfront funding, responsibility of the coordinator’s office. Create pilots
that will test increased investment to physicians for adoption of EHRs
conforming with standards, and use the results to build a generalized business
case. In other words, and I think we have heard a little bit of this in the
previous recommendations, use pilots to expand the proof of the value, and feed
that back into the system. It also may be possible to standardize some of the
adoption of a local or regional NHII, so that everybody is not reinventing the
wheel, and we can start moving things forward and use lessons learned.

Second, establish a mechanism for providing grants and loans with a match
requirement; we felt that was very important, also loan guarantees from public
and private sources, this should not all be government funded, to finance
upfront adoption from health information technology. Also, we want to consider
tax credits.

As part of this, we might create a network of regional health information
technology financing authorities to manage the grants and the loans for the
EHRs, and to assist in the development of the LHII highway that was talked
about yesterday. These regional authorities could be like the center of
expertise for the financing aspect of these developments, and useful broad
dissemination of best practices or lessons learned from financing.

Private payor compensation. We felt this could be the responsibility of the
alliance that the payor and purchaser group discussed yesterday that they
wanted to form, along with Medicare and public payor reforms. We also want to
see reforms in reimbursements to encourage appropriate use of health
information technology, including the care coordination and disease management
and those aspects that can be benefits from adopting these systems.

Second, paper submission of quality improvement data from an interoperable
system. This would be a payment from payors for each office visit, example,
five dollars. The information would go to an entity that would create quality
reports and feed it back into the clinicians practices, so they get a benefit
from it, the incentive being to use an interoperable system.

Next we have equitable payments by all payors for the ongoing use of
improved outcomes from information technology. We discussed many ways of
deciding what metrics would be used, who should be involved in deciding what
those metrics are, and how they would be measured, how they would be
documented. That is quite a bit of work that would need to be done there.

Finally, we wanted to address equity across disciplines. If you are going
to pay for performance, there are some discrepancies in the metrics, so do a
gap analysis to insure that there are consensus quality indicators for each
discipline leading to pay for performance, based on clinical information from
EHRs. We didn’t feel like physicians should be penalized if their specialty has
pre-measures, or there is a lag in developing the kind of metrics that you
would use.

Finally, create special ENM codes for use of EHRs. There would be more
funding for greater use, and you would have to show that there was a
contribution to the local health information infrastructure.

Thank you for the opportunity to be here. This is an exciting time.

DR. LUMPKIN: Thank you very much. Next is the report on standards and
architecture. Mark Overhage.

Agenda Item: Architecture

MR. OVERHAGE: I would like to take a moment to thank or blame as the case
may be my other reporters, Bill Braithwaite, Paul Tang and Chris Shute, and all
of the literally hundreds of people who participated in the four separate
breakout sessions.

We had a huge number of recommendations that percolated through those
groups, which were distilled down by each group, and then we worked very hard
to synthesize and hope that each of them are represented here. Obviously people
won’t see all of their own words here, because we have tried to synthesize and
combine.

In the first recommendation — and this is the same recommendation as was
made last year, and I think is consistent with the framework that was presented
on Wednesday — is the need for an interoperability body. The office of the
national coordinator should identify or convene in partnership with the private
sector an independent body focused on interoperability with the appropriate
authority, funding and support. This may seem simple, but I think all of the
groups, each and every one of them, had this as one of their major
recommendations that percolated to the top. They thought it was critical for us
to make rapid progress to have such a body.

There was a lot of discussion about the characteristics of a body like this
that it would have to have, that were reflected in some of the other summaries,
including that it has to be permanent — this is an ongoing process, not a
one-time thing — that it has to have broad representation, and that it has to
be a working body, it has to have actual staff or ability to contract to get
true work done.

One of the first jobs of that interoperability body should be to translate
the strategic framework into a tactical plan with specific manageable,
achievable and measurable stops. There was a great deal of emphasis in the
discussion on the need to have expectations for when some of these major
components and steps might be deliverable. I think that is an issue step for
people to be able to plan the regional organizations and others to be able to
plan and help move this forward.

The next job that we outlined for the interoperability body is to
promulgate a variety of fairly specific interoperability tasks, including
developing functional requirements or business processes as defined by the end
users. I wanted to emphasize that the groups felt very strongly that this was
not proxies for the end users. It wasn’t a professional association or
something like that that could answer these questions, but that we needed to go
all the way to the level of the individual physicians, for example, or other
providers in order to get the best perspective on those requirements and
business processes.

Second is an interoperability model, standards and architectures. We spent
a lot of time, but the facilitators yanked our slides at 8:30, trying to craft
those words better. But there was a clear sense that this is not just standards
in the sense that we have traditionally thought of them, but standards in the
sense of a carefully crafted and integrated set of standards that are chosen
with implementation guides that allow them to be appropriately implemented, so
that you achieve — and I hesitate to use the word — plug-and-play
interoperability. Then the need for testing process and procedures built around
that information.

This may seem like something we could have included in one of the other
slides, but it was so important, we thought it was worth culling out, and that
is security and privacy. The interoperability body should develop and establish
the infrastructure to facilitate implementation of security and privacy
mechanisms.

Next was the notion of some discussion over the exact word here, reference
implementation, so don’t take that too strongly. But the interoperability body
should conduct a reference implementation demonstration project within 12
months that implements specific use cases that define its scope, that an
implementing test is defined by the interoperability body, and conducts a
validation of the integrity and function by end users, make sure it meets those
business needs.

Patient identifier, not surprisingly, came up. There were mixed thoughts
about this, so since we are presenting to NCVHS, we thought they needed another
job, so the NCVHS should recommend within six months whether a national patient
identifier should be used within NHII.

Some of the groups for example suggested that there needed to be proof that
you didn’t need one, in other words, that perhaps there could be a pilot done
that demonstrated that you could without a national identifier or unique
identifier actually integrate information as a component of this kind of work.
But clearly there was an absolute need for clarity on, are we going to wait
until there is a unique identifier, or are we going to go forward assuming
there is not. That was a very clear message from all of the groups.

Lastly, and this duplicates to some extent the organizational group’s
recommendation, the office of the national coordinator should identify and fund
an entity to create educational and startup resources for LHII early adopters,
practices, communities and hospital systems, and there are examples listed
here, of what might be present.

This came up in our discussion in part because of the interaction of
standards and architecture with policies, processes and procedures. They can’t
be done in isolation. So I think all of those things fit together.

I thank you for the opportunity to report these results this morning, and
look forward to your great progress. Thank you.

DR. LUMPKIN: Thank you very much. At this time we have time for comments
and questions. Again, David, welcome. By the way, we agree with everything that
they asked you to do.

DR. BRAILER: Every word. I have taken notes.

DR. LUMPKIN: Welcome. Any questions yet from the committee? We will have
time to discuss.

MS. HARVEY: Good morning. I am Valerie Harvey from Robert Morris University
in Pittsburgh, Pennsylvania. Yesterday I remarked about the importance of
considering an appropriate model for data sharing. Data sharing is implicit in
several aspects of interoperability and developing the personal health record.
We do have models that exist, in particular the integration agreement process,
which is a formal process for data sharing with which the Veterans
Administration has extensive experience. We should also take into account the
general ideas of medical informatics with regard to the context of medical
data, because they are somewhat different from business data, as everybody in
here knows.

Also, I pointed out yesterday that in connection with the personal health
record and associated health processes, that there are at least four and
possibly more populations, somewhat small, but that have peculiar needs and
risks or possible benefits. Among these would be for example individuals who
are in the federal witness protection program and may need some
re-identification, to be carried out with great care. We also would notice that
there may be some opportunities with regard to adoptive children, and there
probably should be contact with the appropriate organizations that deal with
adoption procedures, to make sure that whatever is done is of appropriate
benefit, and can deal with all the complex legal issues that are involved in
the records for such individuals.

Also, in the case of sex or gender ambiguity, always a difficult topic in
our society, there are two classes of individuals that might have special
needs. First of all, the intersexed, because in some cases as has been noted by
advocacy groups there are individuals who manifest ambiguous genitalia on birth
and are subjected to involuntary surgical intervention. In these cases,
sometimes important medical information is obscured, which may be important
later in life. Plus, they may have some important re-identification needs,
depending on the nature of their particular condition.

Similarly, there is another group different from that, for those who have
gender reassignment, that may need particular care with regard to
re-identification because of the fact that they can become unemployable if
prior identification is revealed under certain circumstances, and suffer other
serious consequences in their social life.

DR. LUMPKIN: Thank you. The next speaker is going to be microphone six.

MR. TAFFEL: My name is Bruce Taffel, medical director for Blue Cross Blue
Shield-Tennessee. I have some concerns about protections and consideration for
early adopters of electronic medical records, specifically with regard to
incentives and protections against changes that may occur as new standards are
developed.

I think it is going to be very important that we not forget the early
adopters. Those were the pioneers, and those were the people that will also
need consideration in possibly revamping their systems and having to pay a
premium to move to newer standards. So I think that is one point I would like
to make. Thank you.

DR. LUMPKIN: Thank you very much. Microphone three.

MR. SCHULER: Good morning. My name is Rick Schuler. I am Vice President and
CIO of Atlanta Regional Health Care. I didn’t notice any mention of incentives
related to health systems and hospitals. As most people know, traditionally
they have been the ones to fund local initiatives, and I am just wondering what
kind of dialogue might have been in the groups, or if I missed something, what
has been talked about.

MS. CHRISTIANSEN: There was at least in one of the groups that I am aware
of not much representation from other providers, so it was very heavily focused
on physicians. The work paper that we had had physician background in it, so
there was some discussion, but primarily that was the focus of the discussion.

DR. LUMPKIN: Thank you. We will go to microphone number five.

MS. DAVIES: I am Jack Davies. I am with Inland Northwest Health Services in
Spokane, Washington. I believe it was the governance work group that made a
recommendation that very quickly we define what an LHII is. I strongly endorse
that. As a community that is long down the road of establishing an LHII, that
would be very helpful for our planning. Also, I believe it would be very
helpful for funding agencies who are getting ready to put out new grants and
new programs to help the developing of LHIIs.

As an example, the AHRQ health information technology grants that were
given out this year had a much broader, almost patient safety focus, CPOE, bar
code medication verification and so forth. It seems as though from the content
of this meeting that the focus of LHIIs is more in the area of EMRs and
electronic data exchange. So we need help in understanding where we need to be
prioritizing for the most effect and most beneficial impact on the system.

Thank you.

DR. LUMPKIN: Thank you. Back to microphone five.

DR. MARTINO: Good morning. My name is Dr. Janet Martino. I am recently
retired from the Air Force, where I spent nearly ten years working on
interoperability for highly complex systems in DoD health affairs. I was the
architect and standards implementation manager. I also was the deputy project
manager on GCPR, government computer based patient record, which was the
beginning, the first major step, that DoD and VA took to begin sharing data.

I now work for Medic Alert Foundation. My experience has shown me that if
you want to have true interoperability, in addition to the data standards and
the messaging standards and the formats that we have been talking about all
week, no one is mentioning the idea of standard interfaces between component
based EHRs, not monolithic, soup to nuts, I do everything and you stick with me
or you can’t go to any other vendor. We have got to start pressuring the
vendors to break their systems into meaningful components and then create
through a standards organization standard interface definitions, where you have
a service called an amplifier, you have one called a CD player, you have a
turntable. Those are components, and they are offering common services, and
everybody can go to the store and buy anybody’s amplifier and just plug it in.
The data will move, because we have defined the data that move as the
electronics between, but we also have defined the interface, which is an RCA
plug of a certain dimension. And we know the processes, because the service of
an amplification is well defined.

I mentioned turntable, because we know that turntables need preamps,
because the turntable makers know that the amplifier can only do so much with
an input. So these are all really well defined. If we can’t have testing that
involves vendors bringing their products in, plugging them in and having them
work without spending three days of techies staying up all night to massage it
to get it to work, then we have got a problem.

That’s it. Thank you.

DR. SHIELDS: I am Dr. Mark Shields, from Chicago. I think the committees
have done a wonderful job of summarizing. I think the one component that is not
there is scope. If our goal is to have 50 percent of physicians on an EHR that
is interoperable in ten years, we must have significant dollars given to them
through subsidies. This is in the scope of $15,000 per physician. We have
200,000 physicians that we want to have, that is four billion dollars. That is
actually small dollars for the health insurance industry, but that is the scope
that we need up front. I think that scope issue needs to be included in these
recommendations.

DR. LUMPKIN: Thank you. Back to microphone five.

MS. BICKFORD: Carol Bickford, American Nurses Association. I have two
points, one on the incentives. It was very biased to be physician only. I want
to encourage you to make sure that you are inclusive of all practitioners.

Second, I raise the question on the standards and architecture section
about how are we going to assume that we have a human computer interface for
our consumer population as well as our practitioners, that is effective,
supportive, consistent across the board. So where does human factors fit into
this discussion?

DR. LUMPKIN: Good point. Did someone want to respond t that?

MR. BOUTIN: There was not a lot of discussion about applications in the
groups. I think that people just left that off. I am thinking that if the
applications are a plug-in into the architecture and not necessarily something
that the standards architecture or the interoperability group talked about.

DR. LUMPKIN: We will go back to microphone five.

MR. KOSTER: Good morning. My name is Francis Koster. I am from the Nemours
organization, which has 400 employed pediatric subspecialists all on an EMR.

As I have sat through the last two days, I had two random thoughts. One is
that of the approximately 600,000 physicians, about 65 percent of them practice
in groups of three or less. There is a bias in our thought process, because
many of us represent rather large organizations. We tend to think in terms of
central solutions and connection of large blocks of data and infrastructure. I
would recommend that the committee pay some considerable attention to making
available an easily installed web-based facility for that 65 percent of the
American physician population that simply will not be able to play in this
arena unless we give more consideration to that.

The second point I would like to suggest is, for many people who are
thinking on the public policy level and not the architecture level, there seems
to be an assumption that a lot of the data on interoperability will be done on
point to point interfaces. I think there would be great public value if the
central body were to make available interface engines which had standard
definitions, such that all vendors could simply upload and download data.
Otherwise we are going to create the guaranteed interface employment act here.

We already have 87 interfaces in place, plus an interface engine. I am here
to tell you, you cannot build what you are talking about in that conceptual
model. So I would urge you to think about some form of, if not public utility,
at least public standard tool, freeware, shareware, call it what you will, that
would then become available to all of us.

Thank you.

DR. LUMPKIN: Thank you. Microphone three.

MR. KIDD: Charles Kidd. I am a consultant. I have a question for the
committee. What is the timetable and medium for responding to these
recommendations? And for those that are accepted, where will we learn the
timetable and the commitment for their implementation?

DR. LUMPKIN: The question for the committee, what will happen is that the
recommendations made to this meeting will be received by the committee. We will
forward them, probably mostly without comment, to the Secretary, which will
allow the Secretary to formally receive those, for those to be posted in a
letter that we will send in our September meeting.

After that, there are such a wide variety of recommendations, I would
suggest that you follow the activities of the office of the national
coordinator for health information technology. I think a number of these you
will see in the strategic plan, the decade of the health — I forget the title,
the decide of health information technology. A number of items are there in the
plan, and I think that David is committed to being accountable for
implementation for that, and you can follow it there.

Did you want to add anything to that, David?

MR. KIDD: I just think it is very important for the credibility of the
entire project that people are able to see visibly what has happened to their
recommendations, and that they have not just disappeared into a black hole.
That is easy to follow when you are working at six o’clock at night in your
office, not here in Washington.

DR. LUMPKIN: I think we have heard you. Thank you. Microphone two.

MR. HEARD: (Comments off mike.)

DR. LUMPKIN: Microphone three.

MS. CAULEY: Good morning. I am Kate Cauley, CEO of the Center for Healthy
Communities in Dayton, Ohio. I wanted to just underscore some of the work of
the governance committee. It has been 15, almost 20 years ago since multiple
branches of the federal government had insisted in their funding mechanisms
that communities just like Dayton, Ohio put together collaboratives and make us
work together.

I don’t want it to be overlooked that now, all over the nation, there are
these groups of people who, like it or not, have been playing together pretty
well in the health care arena, and they can definitely be called upon. At least
their experience should be tapped in creating these LHIIs. All of the research
and statistics that I have read thus far has suggested the best technology and
the best financing will not go very far unless you get boys and girls to play
in the same sandbox together.

So call on us, those of us who have been doing this in the heartland, and
learn from our experiences, and make the process collaborative.

DR. LUMPKIN: Thank you. Microphone six.

DR. SULLIVAN: I am Tom Sullivan. I am a solo practitioner in cardiology.
Just a few weeks ago, I completed a term as president of the Massachusetts
Medical Society.

My comment is addressed to the recommendation from standards and
architecture. I thought I heard Dr. Overhage say that they wanted to not use
the proxies for the end users. It sounded to me like everybody who is here
representing an association might have some difficulty with that.

I’d like to say that my state society brought the continuity of care record
to life in ASTM. I couldn’t have done it without them. In addition to that, a
number of professional medical societies, the AAFP, the Academy of Pediatrics,
the American Medical Association, are the ones who really made this continuity
of care record something to look at.

So I am just a little concerned that these proxies or professional medical
organizations might not be part of this. I am concerned. I worry about the
influence of academics and a small group of informaticians, I’ll say, or
informaticists, whatever. So I encourage NCVHS to indeed involve the
professional medical societies as well as the other proxies, whether that means
AARP or the Foundation for Accountability, or the American Nurses Association
or whomever.

Thank you.

DR. LUMPKIN: Thank you. We are going back to microphone six.

DR. SCHNEIDER: I am Joseph Schneider from Texas. I am a pediatrician. I am
here with the American Academy of Pediatrics. I was in the incentives group. We
had so much fun talking about everything else that one topic that didn’t get
mentioned was Medicaid.

Some providers, hospitals and other organizations are really heavily
Medicaid dependent as opposed to Medicare dependent. Medicaid as many of you
know is a federal program, but it is largely run by the states, and has quite
different rules in each state. My recommendation is that Medicaid should be
incentivized to take the same steps that Medicare does relative to funding
incentives, quality and standards relating to EHRs and LHIIs.

Thank you very much.

DR. LUMPKIN: Thank you. Microphone two.

MS. FRAZER: (Comments off mike.)

DR. LUMPKIN: What we should take away from your comment is that we need to
look at the recommendation that have a code, and let’s look at the best place
or places for those codes to appear, correct? Thank you. Microphone six again.

MS. SHAFFER: Hi. My name is Vi Shaffer. I am vice president of Cerner
Corporation, one of the folks that is trying to help this effort. My request is
for a parallel effort that I think will dovetail with the accomplishments of
the NHII. It is on the topic of specifications of quality measures.

While there have been some good efforts to bring closer together the exact
definitions of the measures of the joint commission’s National Quality Forum,
all of the registries out there, NCQA, et cetera, the measures that they cover
still do not exactly match. Many of them, particularly the good work of the
National Quality Forum, lack the specifications necessary for an information
system supplier to incorporate them into the system. Since the information
systems will capture and can prompt the actions that one gets through those
processes, I ask you to look at a parallel effort, working with JHCO, NCA and
QFM, particularly entities like the trauma registries, to bring those standard
data definitions together and to synch them up with the nomenclature you are
developing, so that we can act upon them consistently within the supplier
community.

DR. LUMPKIN: Thank you. Microphone number two.

MR. ANDREWS: I just want to get back to a question put before the committee
about reporting recommendations. I think I understood that the recommendations
are going to be reported through your committee to the Secretary at your
September meeting. If that is the case, there has been an awful lot of momentum
building this week for doing it now. Can we have these recommendations reported
immediately so that we can get an early feedback?

Thank you.

DR. LUMPKIN: I appreciate the sentiment. However, under the FACA, which is
the Federal Advisory Committee Act, we are required to follow certain
procedures. However, the purpose of this hearing is to facilitate that process.

Now, while our official recommendation on the report back from the
committees may not be until September, I have heard a rumor that there are a
number of federal staff here, including even the national coordinator for
health information technology. The recommendations that you make here will fly
very quickly to the ear of the Department. The formal recommendation will
follow in September.

So we heard you, we knew that, and that is why we have structured it
particularly in this way, to get those recommendations out. Through this
process, there are a number of things. We don’t just want to get the
recommendations out for the Department to look at as they are moving forward,
but also for open discussion. Our hope is that people hear these
recommendations, want to make additional comments, those will be, as all the
recommendations to the NCVHS are, public documents and can be further debated
and discussed.

So the purpose of this particular hearing is to get it open, into a fashion
which under the Federal Advisory Committee Act will allow it to be discussed,
and yet still have full participation and understanding by the Department.

Microphone three.

MR. DICKLER: I’m Bob Dickler. I am with a technical advisory firm in the
Boston area, working in the ambulatory care space. I was in the governance
group. I think our reporters did a phenomenal job reporting on a number of the
very key items, but there are two items that I would like to address that I
think were embedded in their discussion.

The first is the ability for the coordinator’s office to help the local and
regional level work with the governments in the local and regional areas,
especially if you have an LHII that is processing state loans. There are
multiple regulations that need to be dealt with, and they are going to need
some assistance from the top down to deal with the local areas and bring some
of the LHII information and the coordinator’s office to a regional level and
even a local level.

The second recommendation was on process. There are a number of groups here
who are thinking of starting an LHII. They have a number of stakeholders that
have come together, but now they are trying to figure out how to move forward.
I believe the coordinator’s office can provide assistance and guidance, in
addition to the resources that we have talked about, guidance specifically
about what do I do, what is my framework, what are my goals, what is the
strategic planning involved that these organizations need assistance on,
because then they are now able to determine what their methodology is and what
their project plan is, and looking for the coordinator’s office to provide that
assistance.

DR. LUMPKIN: Thank you. Microphone five.

MR. KLEINMAN: My name is Larry Kleinman and I am from Nemours and from
Quality Matters, Inc. I’d like to make two comments, one at a detail level, one
at a more fundamental level.

The detail level relates to the recommendations about incentivizing
physicians for performance based quality measures. I think in concept, it is a
wonderful thing, but I think in reality it is problematic from at least two
fronts. One is the need for valid reliable and statistically meaningful
measures that capture more than random variation. I’m not sure that we have
demonstrated that we have such measures on an individual physician level. So I
think before we put money behind it, we ought to be sure of what we are putting
money behind.

The other piece, and the more disturbing piece, is that predictably,
measures of complexity and patients with special needs lag behind those for
more generic sorts of things. So there is the potential to incentivize
physicians to not care for complex or vulnerable or socioeconomically
vulnerable patients because their performance measures may not be at the same
level. I think this needs to trump any other considerations about incentivizing
until we can be assured that we are not going to tell physicians that they are
going to get paid more for caring for easier to care for patients.

The other piece I would like to comment on is that with all the wonderful
work that has been done at this meeting, it has been based on a number of
assumptions. Those assumptions include that an informatics infrastructure
should be built upon an electronic medical record, which may or may not be
correct. I suspect that it is, but I don’t know that it is. It has been based
upon the fact that LHII is the way to roll out implementation, which may be
correct, but I don’t know that it is.

I would encourage us to keep in mind as we think about this and as we go
through implementation that we should try to be explicitly aware of those
assumptions that we made, and during the course of implementation and during
the course of rollout, continually to test them and challenge them to see if it
still makes sense. It may well be that there are other approaches that would be
more fruitful that just weren’t at the basis of where we began. So if we began
at the wrong place, we may have done all good work and not end up getting to
the right place. I think we should just be watching ourselves, learning,
thinking, challenging all along the way, even as we move forward.

Thank you.

DR. LUMPKIN: Thank you.

MR. SUMMERS: My name is Kent Summers, Purdue University School of Pharmacy.
One of the stakeholders that has been notable to me in its absence here is
pharmacy. And in terms of component information, it seems to me that could be
one of the most important components of information available.

In my experience at a large national HMO, we found that by giving
physicians access to patients’ prescription information, which is accurate and
timely, physicians were more likely to participate in our disease management
programs.

So what I am suggesting is that if the committee could bring in pharmacy as
a key stakeholder, I think it would help with the incentives for physician
participation.

Thank you.

DR. LUMPKIN: I think that is a good point. Simon, do you want to talk a
little bit about the e-prescribing work that we are doing?

DR. COHN: This is certainly not meant as a long discussion about
e-prescribing, but I think as most of you know, under the Medicare
Modernization Act of 2003, the National Committee is responsible for
identifying standards-free prescribing.

Indeed, we are working on those recommendations. We are hoping to see some
first recommendations coming out for the September meeting, probably as a
companion document to all of this. Certainly one would observe that the
pharmacies and pharma generally is very involved in that effort.

I think a previous comment and question from one of the speakers talked
about the concept of components. Obviously one can look at a whole electronic
health record infrastructure in LHII, or one can talk about functionality as
the wedge moving us forward. I think you are probably referring to this idea of
components, making sure that there are no dead ends, making sure that all of
this will all fit together, but making sure that e-prescribing is a key piece
there.

I think the pharmacists are with you. Hopefully most of the industry is
with us on this one. It may turn out to be a leading edge activity as we move
towards an LHII.

I don’t know if that quite answers your question, but I will tell you,
NCPDP and the pharmacies and others are tremendously involved in this, and are
thought partners in the activity.

Jeff, do you have any comments?

MR. BLAIR: You covered it well.

DR. LUMPKIN: The committee has already conducted how many hearings?

DR. COHN: I think if I counted, I might get depressed. I will say that we
have another six days of hearings between now and the beginning of September,
including three days next week. We have had four to five hearing periods,
probably 12 days of hearings, roughly guessing.

DR. LUMPKIN: There is a fairly extensive list of stakeholders that we are
required to consult in the process of coming forward with our recommendations
under the Medicare Modernization Act. We are conducting hearings to do that. If
you look at our website, ncvhs.roseliassociates.com, the list of the hearings are on
there, and as this meeting is, there are also webcasts, so you can listen to
it.

So thank you, it is a good point. Microphone six.

DR. JAGANNATHAN: I am Jaggy Jagannathan. I am a researcher at Medquest and
a computer science professor at Western University. I am going to make two
comments, one about something I know about and two about something I absolutely
know nothing about.

The first one is, I wanted to endorse this notion of complement based
architecture and sole source architecture. As we move forward in defining more
clearly the requirements of EHR, it is not just enough to focus on messaging
paradigms, but you should also focus on architectures and interface
specification. I think it is a critical element of our version for LHII.

The other one which I was going to talk about is an intriguing idea. It is
this classic thinking out of the box, along the lines of challenging the
assumptions, which somebody before me mentioned. This was not my idea. It was
an idea proposed by an IBM researcher, I believe his name is Adam Charbot, and
he basically indicated the notion that everybody has a bank record. Everybody
carries a banking card, and if you want to put your money in, you go to a bank.

Why not have a personal health bank, an independent body, to which you go
and submit your personal record, and they are the custodian of that, and the
person becomes the arbiter of who gets that information, just like the person
decides who gets the money. These banks, there could be thousands of them, but
the health information is integrated on the person’s banking system. You may
choose to use two or three, if you chose to put money in different places.

I thought that was an intriguing idea. I thought there was a policy in
there which said that they were going to give incentives for people to create
their own community health record. Why not create a personal health bank? I
thought it was an intriguing idea. I wondered if anybody had even discussed
this. I believe it is an idea for research, and I would propose that.

Thank you.

DR. LUMPKIN: Thank you. Microphone six.

MR. FITZGERALD: I’m Todd Fitzgerald. I am a systems security officer for
United Government Services. We are a Medicare fiscal intermediary. I am also on
the board of directors for the HIPAA Collaborative of Wisconsin.

We have talked a lot about urgency. I think we are seeing that ten years
isn’t a long time. If we look back to HIPAA and where we are today, we can see
that is about how much time has passed. We are still struggling with some of
the interoperability issues. We have collaboratives around the country that are
discussing things like e-mail standards and how we securely pass information
between each other.

I think we have to move quickly from demonstration projects to standards
that can be used by everybody else, because there is a lot of collaboration
that is going on, but people are trying to find out those different solutions.

Another point I would like to make is with respect to Medicare. We still
have a prohibition on the use of the Internet in communicating with providers.
I’d like to see us use this platform to accelerate the adoption of being able
to use the Internet. There are secure technologies out there. Let’s get moving
and let’s try to move that forward.

DR. LUMPKIN: You mean we could use the Internet? Microphone four.

MS. HARVEY: Valerie Harvey from Computer and Information Systems at Robert
Morris University in Pittsburgh. There is obviously a great dependence in this
enterprise that is envisioned here on telecommunications technology. Many
people of course are familiar with the very secure forms that might be used to
support telesurgery, teleradiology and activities of that type, but also as has
been mentioned, other parts of what is being developed here, designed here,
envisioned here are dependent upon what people tend to call the commodity
Internet. That is the technical term that is used for the open Internet as we
know it.

I think that everyone in this room is aware of some of the weaknesses of
this technology. The e-mail problems, the spam, the occasional interruptions
because of storms, of rogue software, things of that sort, which can affect a
variety of enterprises.

I think that people don’t consider adequately, and haven’t so far in spite
of the vital nature of the use of telecommunications, there is a tremendous
devotion of resources on the part of industry and the public sector that we are
envisioning here. In order to secure the reliable use of this resource, there
may have to be infrastructure changes, not our infrastructure, but the
infrastructure of the Internet.

Certainly the largest companies involved are considering this and trying to
solve the problem, like Microsoft, for example, with authentication strategies.
There has been a lot of talk about whether trace-back capabilities will supply
the inevitable tool. This carries with it some additional policy considerations
that have to do with privacy, for example, yet they are able to trace back
everything on the Internet. But some people think that is the only solution.
There are non-performance degrading approaches that can be applied to this
problem.

So what I would suggest here for us to consider is that we ourselves in an
entirety become a stakeholder in this global issue — not simply international,
but global issue of how the Internet resources reliability used to be assured.
I thought about this as I was at a demo of a PAC system at the Anderson Cancer
Center in Houston in February, and sitting behind five firewalls.

I think many of you know the effort it takes every minute to secure some of
the hospital services that we now have, and how difficult and challenging that
is. So I think we would want to recommend that we play a role as a stakeholder
and take action to support any of the changes in either industry or in
standards that will move us forward. An infrastructure change, if implemented
at noon today, might take years. So every minute that we wait, we delay the
initiation of necessary changes in some cases.

Thank you.

DR. YASNOFF: I wanted to bring peoples’ attention to the fact that there
was a report in 2001 from the National Research Council Computer Science and
Telecommunications Board called Networking Health: Prescriptions for the
Internet, that dealt in great detail with these very issues, and made a number
of recommendations.

DR. LUMPKIN: Further, this work group had a series of hearings on this and
did make recommendations encouraging the Department of Health and Human
Services to get more involved in some of the national collaboratives within the
federal government related to the Internet.

Currently, if I remember right, the National Library of Medicine and NIH
are the primary representatives, and we encourage broader representation from
HHS, but that was before the arrival of the national coordinator. I think his
office will play a role in that, too.

We are going to go to microphone two.

PARTICIPANT: (Comments off mike.)

DR. FRANK: I am Robert Frank with Advanced Health Care in Milwaukee,
Wisconsin. As a clinician, my comment goes to standards and architecture. That
is, as this bill goes forward, I can envision where the amount of documentation
of data within a patient record will grow exponentially. The need to have a
robust search engine available at the point of care for the clinician to use is
going to be necessary and should be strongly considered as part of any
demonstration project that goes forward.

DR. LUMPKIN: Simon mentioned the issue. We had some initial discussion; we
thought 640K was big enough for a record size, but we have changed. I think
your point is a good one.

Let’s go back to microphone two.

DR. ROMEO: (Comments off mike.)

DR. LUMPKIN: Before you sit down, I’m sure everyone else in this room wants
to know, does that include performance codes for use in EHR?

DR. ROMEO: The answer is no.

DR. LUMPKIN: Thank you. Microphone two.

MR. DICKINSON: My name is Gary Dickinson. I am an independent consultant. I
am also co-chair of the HL-7 and the HR technical committee, which has just
produced the draft standard for trial use on the electronic health record
system functional model.

I would like to point out that incentives that I am seeing coming forth in
this program seem to incent the industry in the direction of the same old
stuff, in the sense that business as usual — that we have a bunch of
fragmentary systems and disparate architectures across the industry,
particularly within big organizations. I would like to see two tracks at least,
one of which says we need something to bootstrap ourselves today to get
ourselves up to speed and to begin to do something, but that we ultimately need
a strategy for an electronic health record which relates to its origination,
its management, its interchange and its ultimate use that is robust, so we can
use it for clinical purposes, and clinicians can trust what they get.

When I look at virtual medical records and schemes such as that, I am
concerned that there may be instances where a record presented is not a
complete record, and there is no way for the clinician or whoever is using the
record to know that. Furthermore, that data presented today upon which I as a
clinician may make a clinical decision may not be reproducible tomorrow, and
therefore I can no longer justify that decision based on the absence of data
that I had when I made this decision originally.

So I think there is some major issues that we have to address in this
industry in terms of robustness. An ability to put this as at least a co-equal
path forward to, let’s do something now, so that in ten years we can point out
that we started out with something that began to make progress, but that
ultimately we ended up with a robust, complete solution for practitioners, for
patients and everyone affected as crucial.

Second point. I worked in HL-7 for 15 years. I’m not so proud of that, but
that is the truth. We are only now coming to terms with the fact that we need
to have requirements ahead of specifications.

MR. MC CUTCHEON: Hello. My name is Jay McCutcheon. I am from a fledgling
LHII in South Bend, Indiana. In many of these sessions we have talked about the
health information exchange or the LHII and the EHR, and sometimes I wasn’t
sure what we were talking about, but it got clarified as we went.

What I would like to emphasize is the relationship or expectation that we
ought to have with the formation of LHIIs in not only gathering data and
providing access through some vehicle to clinicians, but also the necessary
coupling or connections to the EHRs in the community. In other words, if there
is an LHII as you do grants and as you do specifications, while we are waiting
for interoperability and all the rest of the standards, that part of their role
could be or should be, depending on your advice, the capability to connect up
data into the EHRs in the community, especially for the three to five physician
group that we heard about before. Secondly, the CCR record back from those EHRs
into the LHII.

Thank you.

MR. HARRINGTON: Good morning. My name is David Harrington. I am the chief
technical officer of the Medic Alert Foundation. First of all, I would just
like to tell everybody what an inspiring experience this has been. This is
proof positive that we can collaborate. Look at how many people are still here
on day three. It is pretty amazing. Give yourselves a hand.

I just wanted to briefly comment on one gentleman’s comment about the
notion of an electronic health record bank. The Medic Alert Foundation, which
has been in business for 48 years, is an electronic health record bank. We have
two and a half members, or depositors, if you will, in the United States alone.
So it is a viable concept, and I am here to tell you that we want to help
figure out how to extend it nationally.

Thank you.

DR. LEVY: Good morning. My name is Maureen Levy. I am a physician, and I am
also with the Florida Medical Quality Assurance, which is the Florida QIO for
Medicare contract.

I have two questions. One is, are the QIOs going to be considered a
significant stakeholder, since we do get Medicaid money for contracts as it
surrounds quality issues? The other one is, what is the role of the QIO in
terms of developing programs to assist physicians to use or adopt EHR, and
especially in the rural and unreserved areas which we found. We have disparity
of care, we have all different types of issues, and what kind of training,
support, awareness programs will the QIO have to adopt to use the system, and
will this be part of the next scope of work, which comes up next year.

DR. LUMPKIN: Thank you. I think that is a good question. One of the things
that I would encourage you and the other QIOs is to actively engage in the
process. This is true of any organization, although I know the QIOs have a
particular working relationship with CMS and the Department.

What is important is that the goal of the National Committee is to provide
a forum where issues can be heard, either through our hearings or in writing.
People can suggest roles, responsibilities and activities, and then we try to
make sure that what we can synthesize out of that is then forwarded to the
Department. So we encourage you to monitor what we are doing and send in your
suggestions.

Microphone six.

MR. BLUMENFELD: Hi. I’m BArry Blumenfeld. I am associate director for
clinical informatics at Partners Health Care in Boston. I would like to start
just by thanking the committee for all the work you have done on messaging
standards, data standards. I think it has been great stuff.

But as many of these standards organizations have discovered as they
develop those data standards, it is hard to do that without an information
model backing it up. Certainly groups like HL-7 have discovered that their
messaging standards have benefitted greatly from the backing of an information
model.

I guess as we move towards service oriented architectures, as we move
towards a more component based approach, I would like to ask the committee or
to urge the committee that you also examine the possibility of either ratifying
or at least examining the information model that should be backing up the
electronic medical record, and how that might play into an ultimate national
structure for information around medical care.

DR. LUMPKIN: Thank you. I think that the role of the committee has been
since our early days, and certainly since HIPAA, that neither we nor the
federal government with some slight differences in some of the work being done
in the National Library of Medicine, are engaged in developing standards, but
rather to adopting those standards.

The issue of the model is something that we would like to get a better feel
for. Maybe not here, but subsequently, if you have some candidates for models
that we can use as building blocks, I think we would certainly be interested in
looking at those, particularly those that have been vetted by an SDO.

Thank you. Microphone six.

DR. BROCKNER: I am Alan Brockner. I am a pediatrician at Georgetown
University here in D.C., also representing the American Academy of Pediatrics.
I wanted to express my thanks and endorsement of the recommendations on
standards and architecture, and give four examples of how I feel these can help
to capture the energy of this conference, and promote rapid growth within the
NHII.

The first is, I think the education of the LHIIs should include the
continuity of care record that was mentioned previously, that helps to
distinguish information that is of value within institutions at the time of
care from that that is of value for continuity of care afterwards, and may
provide a rapid and efficient route to implementation.

The area of interoperability, we need to encourage and promote two-way
communication between physician information systems and pharmacy information
systems. This is still not possible in half the states. The government can play
a role in making this happen, but education and buy-in from the users on both
sides will be critical.

The investment in SNONED is also going to require encouragement to
integrate and facilitate its use within systems that this process can
encourage.

Finally, there is a critical need for digital signature to be demonstrated
and integrated into the NHII, so that one can have confidence in the integrity
of messages and their origin on the NHII.

DR. LUMPKIN: Thank you. Then our last speaker before we adjourn for a
break, microphone six.

MR. CASSILAS: Hi. I am John Cassilas, Medical Banking Project. I want to
get together with Med Alert and with Jaggy from Medquest, who made reference to
using banking infrastructure. I just want to say that HIPAA has bulldozed the
Berlin Wall between the health care system and banks. You cannot run — you
have banks that are rushing to get into this space as evidenced by press
released, to help implement health information infrastructure.

The policies for privacy and security need to be harmonized between the two
industries. I know that NCVHS has tackled this issue. I know it is complex.
There is a recent letter that they put out, and it offers some very good
recommendations for HHS. We would just want to tell CMS to please affirm the
existing HIPAA regulations so that we can get on with the process of bringing
this technology to reduce costs for Americans.

Thanks.

DR. LUMPKIN: Thank you. I think that if — I’ll speak for Bill Yasnoff,
although he has an opportunity later to speak for himself — but if one of the
outcomes of this meeting are people such as you and the other groups getting
together and talking about ways that different technologies have developed or
different strategies and approaches can be harmonized, we will certainly have
considered this to be a very successful meeting. Too much in the information
space has been people doing one-of things, working in isolation. Obviously the
issue now is interoperability, working together, and that is what the
conferences have been about and certainly what our committee has worked hard
for.

At this point, we are going to take a break until 10 o’clock.

(Brief recess.)

DR. LUMPKIN: We are going to move forward and then we will talk about
measuring our performance in metrics, move from there to research, and end up
with population health.

Suniti Ponkshe.

Agenda Item: Confidentiality and
Ethics

DR. PONKSHE: Thank you very much. First of all, I wanted to say the reason
we have two state representations is not because Paul and I couldn’t agree on
it, but we both had very, very lively groups, and they couldn’t agree on it.
Also, we felt we would be doing injustice if we did not bring forward their own
recommendations in their own words.

First of all, I would like to thank our facilitator, Greg Nicholas. He did
an excellent job of trying to keep everybody on task when everybody wanted to
express their opinion. Our two lead experts, Alan Goldberg and Ken Goodman,
have done a wonderful job of scoping the issue and putting forth the report.

The topic that we had was confidentiality, ethics, privacy and access.
Interestingly enough, nobody in our group talked about ethics. They primarily
focused on confidentiality, privacy and somewhat, access.

The major themes as you will see were related to two issues, one, that some
things cannot be sorted out in a two or three hour period that we had. So we
talked about setting up guidelines or rules or task forces that could focus on
it, and some things couldn’t be focused on.

The process we took was, I would have said it was a democratic process, but
I know this time of the year it is not a good word to say, so it was a very
collaborative process. Everybody in the room came up with their own
recommendations, and then we put them up on the wall, and they voted on it. So
what I am presenting is what was voted by them.

First of all, the key recommendation is to set up a committee or task force
to identify potential users of — I use the word collaborative health
information infrastructure to mean that whether it is local, regional or
national, it doesn’t matter. When you are trying to collaborate, you need to
first identify who the users are, then analyze the gaps between current privacy
laws and what will be needed to support the new collaborative method, and then
develop policies to address them.

The second one had a recommendation focused primarily on the education
piece, educating consumers and providers specific to privacy risks, safeguards
and rights related to EHR and collaborative health information networks. The
group also recommended that this should be funded through foundation grants and
government grants.

Our next recommendation was related to the patient information road map.
Here again, we felt that we couldn’t really come up with any specific
recommendations, but there should be a road map that should be developed to
acknowledge that consumers’ rights are at the front and center of everything we
do, and then set the rules and standards for everything that this collaborative
network will deliver, which would mean content, information flow, rural based
access, audit control, and all of that, that goes with the information network.

The next recommendation we had was, set up a cross country group to create
a working model. These words were chosen very specifically by the group. The
point was that there may have been a lot of talk about it, but there should be
a model that is working that people can emulate from.

The next recommendation was related to setting up a regulation to assign
ownership of EHR to the consumer and then clarifying their rights and
responsibilities regarding ownership, what it means and what they can do, what
they cannot do, et cetera.

Last but not least was a very controversial recommendation. Some people
agreed to it and some people did not. That had to do with the use of
information of the EHR. There was a strong opinion from some people that
specifically it should exclude the data for individual underwriters, and
anything that is exclusive for coverage.

The thought behind that was that sometimes, the information is used against
you when you are looking for insurance coverage. This particular one focused
on, once you put everything up on electronically on a network, a lot of people
will have access to it. The reason I say controversial is, during the voting
process it had equal reds and equal greens, so we couldn’t get an agreement on
that. So that was the controversial one.

But those were the six recommendations I wanted to put forward from our
group. Thank you.

DR. LUMPKIN: Thank you very much. Paul Smith.

MR. SMITH: Thank you. I am Paul Smith with Davis Wright Tremaine. I worked
with Group B on confidentiality, ethics and privacy. I have to say that I
regret that we were unable to achieve interoperability between the two groups.
I have to tell you that it was not for the lack of common standards, which were
clearly mandated at the outset and skillfully enforced by our facilitators.
Maybe there is a lesson in that for all of us.

Our group recognized that effective privacy, security and transparency of
the system is vitally important, not just as an ethical matter, btu because if
people aren’t confident that their information is going to be kept private, and
if they don’t know who is going to have access to it and what uses are going to
be made of it, they are simply not going to participate in the system.

An important starting point, we felt, which echoes the information that has
previously been made available to you, is to make sure that effective consumer
advocates are involved at every step of the process, and at every level of
standards development.

Most of the discussion in our group focused on access, and the need for
effective access. There was a strong sense that there needed to be explicit
rules about who has access to the system, that it needs to entail proper
authentication, non-repudiation, and effective and meaningful audit trails. The
protection of the system needs to extend to items of information that are
currently viewed as falling outside the system, in particular telehealth and
e-mail communications which need to be brought into the system and which need
to be given the protections that are afforded to other health information. Then
there needs also to be system transparency, by which the group meant a clear
understanding on the part of participants in the system as to the uses that
would be made of their health information beyond the ordinary uses for
treatment and payment, and that there ought to be some centralized management
of access to the system by individuals and entities to used it for
non-treatment related purposes, and that that information ought to be readily
available to individuals, so that if you wanted to know who might have access
to your health information through the system, there would be some centrally
managed location registry, where people who had access to the system were
listed, so that you could look them up and see who they were.

Then it was felt also that there needs to be effective enforcement.
Assuring people privacy rights is not going to instil the necessary confidence
in those people. Also, believe that if there are breaches of the system, they
are going to be aggressively pursued and effective penalties are going to be
imposed upon people who misuse the system.

This is a recommendation that has already been made. It is important to
assume a buy-in by educating them about the benefits of the system, not just
for themselves, but also for public health and for research. There was a
feeling that people would genuinely be willing to allow their health
information to be made available for public health and for research, but the
parameters of that access need to be clearly defined and communicated, and
people need to be given a sense that they are in a meaningful way giving
permission for that use of their health information.

There needed to be in the view of the group readily ascertainable and
understandable privacy rules that are not now, and these need to be developed.
People are having a very difficult time dealing with many aspects of the HIPAA
regulation. The one that came up most for discussion in our group is the
interplay between federal and state privacy rules. The sense was that that is
not workable in its current state, and it is going to be even less workable
with the NHII. The federal government needs to step forward and take a
leadership role in resolving this problem for us, either by adopting a
pre-emptive federal privacy rule for the NHII, or if that is not feasible, by
marshaling resources at the state level and at the federal level, so that
people who participate in the system have a clear road map and an authoritative
road map to the particular privacy rule that applies in a given situation, so
that everybody is reading off the same page and knows what to do.

There also in the view of this group needs to be more comprehensive and
readily accessible materials for education and for compliance purposes. HHS has
done a good and serious job with the educational resources that are currently
available, with their frequently asked question and their guidance papers and
the preambles to regulations. But these materials need to be consolidated and
made more readily accessible. In addition, there was a strong feeling that
effective tools for compliance need to be provided, and particularly model
agreements for participants in the system that governed every one of the large
body of relationships that are going to be necessary for people to participate
effectively.

There was a recommendation that — we dealt with the question about the
need to insure adequate location and matching of patient health records. I am
disappointed to tell you that we don’t have the answer to this one, either. We
recognize though that it is a problem.

One specific suggestion that came out of the group was that if there is a
unique patient identifier, that it be privately managed, in the sense that
individuals would have — that the system would accommodate it if individuals
wanted to use it, but that it would not be mandatory.

There was also a strong consensus that HHS should support research or
conduct research and development of privacy enhancing technologies and
mechanisms for incorporation into the NHII.

Then there was a good deal of discussion on the point that Suniti raised,
about what we mean when we say that an individual is going to have ownership of
his or her health information in the system. That concept is bandied about, but
very careful thought needs to be given to the precise incidence of ownership
and control, and they need to be well-defined and accurately explained, so that
peoples’ expectations are properly said and peoples’ concerns are properly
dealt with.

For example, when should an individual be able to withhold information from
the record or opt out of it altogether or in part opt out of it with respect to
certain information, and how do you address, if you give them that right, the
concern that was raised by one of the speakers earlier on, about the situation
of a provider who may be working with less than a complete set of information,
and may not even know that he or she is working with less than a complete set
of information. Then again, when should an individual who has information in
the record be able to restrict access by specific providers. I think there is
an acknowledgement that this concept of individual ownership of the record is
somewhat of a paradigm shift from the way ownership of the record is viewed
today, and those changes need to be very carefully defined.

Then lastly, the group did recognize that there were significant ethical
issues beyond just concerns of privacy and security, and that we need not to
lose sight of those. There were no specific recommendations, but some examples
of how do you manage genetic information and other sensitive health information
that other people may need to know about, what is the appropriate use of
information technology tools in diagnosis and treatment, and what additional
consents are required, particularly in the context of using health information
for purposes beyond just treatment of the individual.

Thank you.

DR. LUMPKIN: Thank you. Now for measuring our progress in metrics, Rainu
Kaushal.

Agenda Item: Measuring Progress

DR. KAUSHAL: I thank you for the opportunity to speak today. Our group was
a bit different. I read the slide from Blackbird because I thought it depicted
our group very well. There weren’t many of us in the room. We were trying very
hard to figure out where to put the X on the curve, and we ended up the day a
little weary and ready for a drink.

We started the day with a quote from Peter Drucker, or an adaptation of
Peter Drucker’s quote. That is, if you can’t measure it, you can’t improve it.
Our group came up with four specific recommendations. The first recommendation
was probably the one that we agreed the most upon and that we were able to
flesh out in the most detail.

This first recommendation was recognizing the critical importance of
measurement in achieving success, HHS should convene and fund — and this is
very important, that the funding came along with the authority — an impartial
expert group such as an IOM committee to define metrics for the measurement of
the National Health Information Infrastructure.

Some further points about this expert panel. We thought it was very
important that a leader was assigned by HHS to take control and responsibility
of this group; that there be a broad representation of experts, that it
shouldn’t just be an academic niche group; that advice by stakeholders should
be incorporated as needed, in keeping with the idea that we need to have
actionable items coming out of these types of interventions, that the
deliverables should be produced within nine months.

We identified three tasks for the expert panel. The first task was to
create clear and consistent definitions of components of the NHII as a basis
for metrics. Some of the terms that we thought need to be agreed upon is, how
are we defining an LHII for the NHII, how are we defining EHRs as we think
about them for NHII, how are we defining something like computerized physician
order entry.

Just to give an example of what we were trying to get at with this concept
of definitions, I pulled part of the white paper that informed the metric
group. In that paper, the authors defined a conceptual model of NHII. This
might be an appropriate model and it might not, but I think it is very
illustrative of the type of work that we thought this expert panel should first
do.

The concept that was put forth was that NHII could be thought of as nodes
and clusters. The definitions go as follows. A node is a physical health care
environment with the ability to store and display and transmit health
information technology. A physician’s practice could be a node, as could a
large academic medical center, so the size doesn’t depend on the definition.

The next concept is that these nodes connect to form a cluster. A cluster
is a collection of providers of health care who share patient level information
electronically, and that nodes have an existing written — and this seemed to
be very important, the fact that it is a written data sharing agreement, that
allows any node to exchange patient identifiable information with another node.

Here is how this model could be pictorially depicted. That is, in cluster
one you have three nodes communicating directly with one another, in cluster
two, the pink cluster, you have nodes communicating with a central repository,
and as these clusters start to cluster, you develop learning from cluster one,
learning from cluster two, and you start developing the framework for an NHII.

So our concept was, after these definitions were laid out, the next step
was to define a set of metrics to utilize these concepts to measure an NHII,
and to develop a methodology to test the reliability and validity of the
metrics. We thought it was beyond the scope of this expert panel to go out and
do that, but to develop the methodology we thought was an important role.

The third role was to define additional test metrics to be released but not
required.

We had three other specific recommendations. The second was using expert
panel definitions and metrics to conduct a multi-level inventory of NHII
components, including both functionality and interoperability. This would need
to include the population that was covered with the existing NHII, and this
type of inventory would occur at intervals.

The third was the creation of an NHII directory. This would be perhaps in
the form of a website documenting existing local health information networks
and sharing the best practices of LHIIs.

Then the last goal that we saw as something that could be accomplishable
over the next three years was determining the effects of existing policies on
the rates of adoption of the NHII. The concept here was that a couple of
examples of policy initiatives that are in place and being considered today are
financial incentives to primary care physicians to EHRs, and reduce malpractice
rates for physicians who are using computerized physician order entry. Given
that we would now have an ability to measure the rate of adoption of the NHII,
we could determine the effects of these existing policies on those rates.

Thank you.

DR. LUMPKIN: Thank you very much. We are going to move on to research, and
Joyce Niland and Elaine Rubin are going to do a joint presentation.

Agenda Item: Clinical Research

DR. NILAND: Thank you. I’d like to echo the previous speakers in thanking
Dr. Brailer and the committee for inviting our comment, and the hundreds of
people who have participated over the course of these days to give their
valuable input.

I am Joyce Niland from City of Hope. I chair the Division of Information
Sciences there, and also I am a developer for another initiative, the NCI CA
big clinical trials work space. Elaine Rubin, my associate, will be doing the
second part of the reporting out. She is from the Association of Academic
Health Centers. I would also like to thank Dr. Harold Lehman and Dr. Peter
Elkin for their work as leaders of this group.

We thought we would start with a bit of a preamble. There were some basic
tenets that we thought we needed to set forth and see if we could get
agreement. We thought we were use a bit of a different format. This is the last
of a long presentation, so something that you might be comfortable with as a
government reporting out. We the people hereby recommend that the NHII insure
that clinical and translational research needs are interwoven through the
foundational NHII strategic plan, in order to form a more perfect union between
the clinical care and research endeavors.

Be it known that we also urge our nation’s government to articulate the
long term vision and mission for research within the NHII, in addition to the
articles set forth herein enunciating our short term actionable articles of
faith, as it were.

Continuing our preamble, we also felt in our groups it was very important
to define research. Although our group was called clinical research, we would
like to contend that the NHII be concerned with all facets of research related
to human health and well-being, including but not limited to clinical research,
basic science, population research, environmental sciences, bioengineering and
informatics. We felt in this way that we would really make the most utilization
possible out of the clinical care information for research purposes. We hope
that we would all hold these truths to be self evident.

Returning to our usual format, we came up with about ten recommendations
for short term priorities. These are not in order by priority, but more in
order of the natural life cycle of research.

The first is a critical tenet that I am glad to see seems to be echoed
here, that the Department of Health and Human Services should develop the NHII
in a manner that encourages the re-use of clinical care data for research. We
think that this will be a critical and excellent way to speed biomedical
research discoveries that are taking such a long time now.

It has been mentioned earlier today, but our group felt that in lieu of a
singular master ID, or at least initially and perhaps long term, the DHHS
should create a task force that looks at some of the existing and perhaps newly
emerging methods to define and disseminate best practices for identifying and
linking unique individuals across multiple relevant databases. And of course,
as we move into research, this will include the research databases as well.
There are methodologies already in existence that can give you a fairly high
probability of this type of match, so if we could come up with a uniform method
to recommend this, that would be excellent.

This statement — the brevity doesn’t reflect the intense discussion that
went on around it, but I think a key thing that we will need to continue to
move forward is a national IRB standard for how we access and process the data,
particularly as we get data sharing across the space of clinical care and
research. Right now, this is a major additional delay in the research process,
and often results in unnecessary restrictions, perhaps, while we do want to
maintain privacy and confidentiality.

We also felt that the HIPAA rules will continue to need to be reviewed and
amended to take into account evolving demands that emerge because of the
universal access to electronic health data, not only for care as we have been
speaking about this morning, but now hopefully for research as well. So the
current HIPAA rules allow this, but if we continue to streamline them, it would
be very beneficial.

Then this is a long one, but basically the idea was that in collaboration
with the health care and research communities, we would strongly recommend that
DHHS and the Department of Commerce should evaluate the capacity of existing
controlled research vocabulary resources in order to support integration of
clinical care and research data. The committee wanted to point out in
particular, it is not purely the vocabulary surrounding the electronic health
record, but as we move into research, there could be animal vector,
environmental and other non-human data that is related to human health. It will
be critical that we are all basically able to speak the same language, and that
these vocabularies hold up and maintain the integrity of our scientific
endeavors.

Once these are established, it will be important to maintain these standard
terminologies in the public domain in a non-proprietary fashion. For example,
the recent licensing availability of SNOMED with a free licensure to
institutions conducting research is a major step forward. However, as we all
begin to utilize this now more frequently and robustly in our research, we want
to be sure that if there are new terms or amendments to terms, there is a way
to curate this locally and to be able to insert these into the vocabularies. I
spoke with Dr. Donald Lindberg who is here, the head of the National Library of
Medicine, and he was recommending this be maintained through the National
Library of Medicine’s UMLS, the meta source, which would be very helpful.

Now Elaine will complete the rest of the reporting out.

DR. RUBIN: Thank you. I want to again thank the experts and all the people
who participated. In my group they were maybe a little less poetic, but no less
expert.

Continuing the recommendations. Funding agencies should promote and
investigators should conduct informatics research that assists in the further
development and implementation of the NHII architecture in a manner conducive
to supporting research, as well as patient care. Again, you see this theme of
the connectivity and the need to not isolate research from the patient care
environment.

HHS should support the creation of managed open source requirements for
interoperable tools, applications and information for end to end clinical
research life cycle, for example in the community private practice or academia.
The group did not want to again rule out any site.

HHS should insure that emerging research work flow processes, information
models, protocol representation and data representation standards being
developed by CDISC, by HL-7, RCRIM and the clinical genomics special interest
group are used as meta data standards in FIN and NHII.

HHS should fund demonstration projects of connectivity between existing
clinical care networks and existing research networks. Again, this theme ran
throughout our work.

CMS should implement new interoperable and universally accessible
technologies to provide Medicare claims data compression and export, for
example, using HLM and ASCII format to the researchers.

Finally, NHII should establish a communication vehicle for the timely and
appropriate data exchange among researchers. What we mean is, communication
strategies and dissemination, to be sure to not forget that, and to be sure
that there are also funds for that. That mean includes comparable research
results and the dissemination of summarized research results, and publicly
accessible databases for consumers and health care providers. So it is not just
for the research areas, but ultimately for the public.

Thank you.

DR. LUMPKIN: Thank you. Finally, population health, Marty LaVenture.

Agenda Item: Population Health

DR. LaVENTURE: Thank you. I am Marty LaVenture with the Minnesota
Department of Health and director of public health informatics. Thank you for
the opportunity in behalf of our group, dealing with population health. We want
to note at the outset that population health included both public health and
clinical quality improvement issues. By virtue of the numbers involved in the
public health area, we feel that certainly more discussion around the quality
improvement area perhaps even needs its own focus in many respects, so it is
related in a number of areas. With a limited amount of time, more activity was
needed.

I want to also thank our co-leaders, Dr. Scott Williams and Dr. Rita
Kukafka, who did a great job trying to modify and move the whole agenda forward
in the activity, as well as our topic experts. The population health leadership
wants to thank the committee here for focusing on population health issues,
especially beginning the initiative from last year with the first conference
and the work that Dr. Bill Yasnoff and others have done to move this population
health issue forward. They are related in a number of areas, in looking at
public health with regard to the framework for strategic action.

We certainly understood, and it was recognized that the group was very
encouraged by the energy and enthusiasm around the framework for strategic
action. But we also recognized that the four goals and 12 strategies within
that framework were not intended to address all of the population health needs,
and that there were wider elements to that. The whole NHII framework clearly
was a very important element, even though the strategic framework from a
population health perspective focused a great deal on electronic health records
and personal health records. Clearly there are bounds around both public and
population health that extends beyond that activity.

One of the early recommendations is that HHS should identify population
health needs that ar reflected in the full dimensions, all four dimensions, in
the NHII model, and assign authority to begin strategic actions associated with
that particular model.

Similarly, in a strategic way, the group recommends to develop a task force
to map population health strategies into a bigger framework of public health,
such as Healthy People 2010, and present those to HHS for action and to all of
you, as well as to the larger public health community such as the American
Public Health Association, which is literally tens of thousands of members,
that need to take informative action around these areas, and introduction of
this concept and focus should be part of their annual meeting for the purposes
of education.

So in looking at the wide spectrum of population health needs, we had a lot
of recommendations and a great deal of discussion. We wanted to also recognize
that the strategic framework is an important element of the momentum.

So the recommendations that we put together, we associated those across and
saw that the population went across all four of the goals, even though it was
cited in goal number four, as you recall, with the recommendations organized
and mapped to the goal and strategy. The mapping isn’t perfect. We did it in a
short time frame, but we think that threads of population health goes across
the strategic framework in many ways.

We begin with recommendations such as this. We need to infuse the full
population health functions into the electronic health records and personal
health records. Right now, that focuses a great deal on surveillance, but it
certainly should be much broader, because that brings to the whole goal number
one of informing clinical practice dimensions of public health and prevention
that are very crucial.

Similarly, in informing clinical practice, the opportunity to increase
broad participation by a spectrum of stakeholders. One of the issues that was
emphasized is who represents population health and public health and clinical
practice, quite a wide dimension of individuals. So that should be reflected
both in the public and private dimensions of the stakeholders to develop the
standards that can be used for the implementation of population health threads
and components associated with LHIIs.

Similarly, define the processes and policies, for example, the privacy
issues and HIPAA related issues, as well as incentives for population health
access across all electronic health records. Again, crucial to the population
component for emphasizing the goal number one in clinical practice.

One of the tactical suggestions that was in recommendations that came out
of the group was to within three years develop the ability to send population
health alerts. We do that to some degree now. They should be embedded and
encouraged to 90 percent of the rural and underserved. Again, the focus into
the rural and underserved areas where we know prevention activities are very
important, and population health data is crucial for important strategies.

Similarly, federal agencies should increase grants to the rural and
frontier areas that accelerate the adoption of an electronic health information
infrastructures, and include population health strategies. The key here is the
population health focus within the LHII for the practice.

In terms of interconnection issues, the recommendation on population health
focused on identifying and engaging the broader population stakeholders to
continue the development of the framework for the strategic action. The
interconnection is crucial when we look at moving and mobile populations around
public health issues and population health issues. It was important to engage
the whole breadth of the stakeholders in that focus.

The recommendation on the personalized care component as well came from
population health, to have HHS establish a goal for consumer choice
enhancement, including the provider information. Outcomes and satisfaction were
some examples of population health and prevention health measures that were
very crucial. Those should be set forth and emphasized.

HHS should also establish some strategies to meet particularly needs of the
underserved and vulnerable populations. Again, those that will benefit the
most, particularly those that are outside of some of the care activities for
the LHIIs and the personal health records for their implementation.

The goal number four had a lot of focus and emphasis in the population
health area. We have a couple of key recommendations. The HHS should adopt a
policy that requires all electronic health records to be capable of community
health surveillance. This is clearly a focus coming, and it is important around
the bioterrorism and urgent emerging issues and threats. Here they got a little
bit more specific, to encourage Dr. Brailer to assemble a public health task
force to identify the core data sets within 90 days. The sense of urgency that
there are some critical pieces, and those should be embedded as soon as
possible.

Similarly, collaborate with other stakeholders, including the consumer
groups, to achieve early consensus on the population health data elements, and
importantly, the functions that are associated with the population health
dimensions.

Goal number four in population health. Within five years, complement and
migrate the national health information systems such as BFRS or NHANES and
others that are out there, how do we not just implement these systems, but look
at how do we transform the collection of data nationally in a more integrated
way, and actively identify databases that can be targeted to do that, including
demonstration projects, as soon as possible, targeted here, recommended in the
first year.

Next, implement the public health informatics core competencies that were
developed by the CDC task force not long ago. They were well developed. They
need to be implemented. Their recommendation was 50 percent of the public
health work force as soon as possible, next year, and 85 percent by 2006, so
that those core competencies can be leveraged to the large work force in
population health that is available, so that we can move this ahead
expeditiously.

Similarly, HHS should require feedback. The critical focus here is feedback
of the value-added information that population health provides, and the
knowledge that comes associated with the data that is has collected. That
feedback loop is essential, and the leadership to identify those and move them
ahead is critical.

Then by fiscal year 2005, HHS should implement HIT demonstration projects
that address all of the population health needs, focused on a number of
different dimensions.

Then, identify and mobilize a task group of population health experts to
establish a comprehensive model, including the detailed structure such as
normalization for the data traditionally collected by population health
records. There is a great deal that is collected now; those need to be
organized and normalized.

Thank you very much.

DR. LUMPKIN: That was a good group of reports. We are going to follow
through in the same way that we did earlier, if I can find my chart. We are
going to start off with microphone four.

MR. SINCLAIR: Good morning. My name is David Sinclair. I am the CEO of a
company called Med Decisions. We are a clinical informatics systems company.

I have two suggestions. First, I think it would be very helpful for those
of us who are concerned about early volume in the LHII environments if this
panel could address the issue of whether or not participation in networks by
consumers is opt in or opt out, and whether or not express authorization for
the storage and transferral of records is required, or whether implied
authorization can be as well.

Those of us who are concerned about very slow adoption rates and hence very
low transactio volumes leading to very high transactio costs would obviously be
tending to vote for opt out situations, where implied consent is sufficient.
But I think that is one of those issues that really needs to be dealt with.

The second one. I have been struck over the last couple of days by our
general reluctance to discuss in any detail the legitimate needs of payors in
this setting for data and access to data on an identified basis. I don’t just
refer to commercial payors, but also to the federal government. We spend a
great deal of time, I think legitimately, talking about other users of this
network, but as we are turning to the government and the commercial payors to
fund all of this, I think I would also suggest that we need to spend some more
time trying to address their legitimate needs for access and use of identified
data.

Thank you very much.

DR. LUMPKIN: Thank you. Microphone four.

MR. JAMES: My name is Linnell James, Blue Cross Blue Shield Association in
Chicago. I am an active member of the HL-7 group that did the EHR standard,
along with about 15 to 20 folks in this room, also participated in the personal
health record group here.

One of the items that was mentioned, and this group has been very much
concerned about, is incentives. I am very much concerned that there is a major
disincentive that has been covered lightly, but needs to perhaps be looked in
more detail. Specifically I would hope this group would take a look at the June
CEO magazine. For those of you who would like to take a look, it is
www.ceoexecutive.net. The article was on health care crisis, and five
multi-billion dollar firms were in the room, along with three of the CEOs of
Blue plans. Let me read one sentence. While acknowledging that wellness
initiatives and disease management programs have proven effectiveness for
reducing costs in some benefit plans, some CEOs expressed concern about
potential legal issues arising from the program.

The point I want to make is, as part of an EHR, we have all been talking
about the importance of clinical decision support and evidence based medicine.
I am very concerned that if we are concerned about speedy adoption, you can be
assured that someone is going to get sued at some point. A safe harbor and
looking at the litigation issues I think will be very important to want to
avoid that disincentive, and also provide potentially another disincentive for
the physicians to take full advantage of the EHR to the extent that they
understand they have some protection as they potentially are on the leading
edge of adopting these EHRs.

DR. LUMPKIN: Thank you. Microphone five.

MR. KLEINMAN: I also served as an expert on the metrics group. I would like
to make four comments. The first is, in hearing the presentation about
population health, it occurs to me that it provides another model we should at
least think about for how to make the national implementation of NHII happen.
That is, the public health infrastructure could provide a centralizing force
with which the LHII connects. In other words, it could be the center of the
cluster, and maybe something that is worth thinking about, and maybe the place
where some of the standards should be developed. It is just worth thinking.

I also think in some ways, the public health area is ahead of the
electronic health record area. Thus, we can as the metrics group suggest taking
learnings from that. I recently completed a national evaluation for CMS that
included dealing with state by state immunization registries. In these states,
immunization registries, which is clearly innocuous data, one would think,
there are remarkably different rules in terms of opt in, opt out, in terms of
issues of privacy.

I think we should keep in mind that if this is so difficult and so diverse
at this point in time as to keep many of those registries from being functional
and useful, that should give us pause as we think about the much more rich data
sets that we are talking about, and the need to lay the groundwork upon which
we are going to be building.

The other thing that I would like to suggest is with regard to the metrics
group. Two parts. One is, I think the suggestion was made to identify
definitions for the various components of the NHII, and I think that is
wonderful. I think we need to take that further and think about the building
blocks. So borrowing from an earlier metaphor, not only are these different
components, but is it tubes or transistors, what is the amperage, the power,
the memory, et cetera. We need to have standard definitions going down the line
not only of what constitutes a CPOE system or an LHII, but how can we
categorize their strength and their extent.

The last thing I would like to comment on is, I think it seems that it is
very important that we think about how we are going to evaluate the impact of
NHII, as well as the extent of implementation. It seems to me that it is
critical that someone begin to develop the set of questions that we think need
to be answered during the course of the evaluation, not only how are we going
to evaluate, but what do we want to know.

Regarding implementation, we probably want to have a sense of how it was
done and what it cost and how effectively it was done. We want to know what was
implemented, and some sense of the context, what the world looked like in that
area before the implementation took place. We want to have a sense of how it
changed practice, how it affected costs, how it affected service delivery.
Finally and hopefully most importantly to everyone in the room, how did it
impact the health of the people who were affected by it.

I think we need to come up within this broader framework, or someone needs
to come up with in this broader framework, a set of specific questions that at
least in aggregate, the measurement and evaluations are geared to answer, to
make sure that none are left out, and that all the LHIIs don’t answer all the
easier, so-called low-hanging fruit questions, and never get to some of the
more complex but still critical questions.

Thank you.

DR. LUMPKIN: Thank you. Back to microphone six.

MR. KAHN: Ladies and gentlemen and chairman, my name is Michael Kahn. I am
a nobody representing nobody except myself. I am also one of the tens of
millions of people whose VCR continues to flash 12 o’clock, because I can’t
reset it. Now my DVD is doing the same thing. I am also one of the millions of
Americans who constantly drop phone calls when I am trying to transfer them to
someone else.

These are just examples of where what started out as being very simple
became very complex, and very quickly became unusable. I don’t want to minimize
at all — I acknowledge that the goals that we want to achieve and the systems
that we are working into are extremely complex. But I would like to remind the
committee and all of us here that the most powerful ideas tend to be the
simplest, even though simple is really hard.

So when I take a look at the standards that are coming out and the
standards that we are being asked to implement, they describe my world, but I
don’t recognize them. I don’t recognize them in the terms and terminologies and
the descriptions of what is supposedly a description of what I do every day.

So my message to the committee and to this community is to constantly, you
challenge us, and for us to constantly challenge ourselves, to respond by
trying to look for how to simplify things, instead of complexify things. I
understand that simple is really hard, even when you are trying to do something
complex.

So I urge that when faced between choices, the committee is facing choices
between really cool techno neat whizzy stuff and the basic but useful, please
choose the road less traveled.

DR. LUMPKIN: Thank you. Microphone five.

MR. LOONSK: Thank you. I am John Loonsk from the Centers for Disease
Control and Prevention. The CDC has had the opportunity to talk to the NCVHS
before about the standards based initiatives of the public health information
network to support public health information systems, and particularly about
also preparedness needs for bioterrorism and naturally occurring events. As Dr.
Gerberding indicated on Wednesday, we are very excited about the opportunities
of the strategic framework of supporting Dr. Brailer in moving forward in this
realm because of the hand in glove fit between these activities of the EHRs,
PHRs and public health needs.

My comment is to emphasize the need for incremental deliverables, and to
further complement Marty LaVenture’s presentation by indicating particularly
the need for incremental deliverables that support national preparedness, and
to broaden that a little bit to indicate that those preparedness needs, and
EHRs and PHRs, LHIIs and NHII need to help support in the public health sphere
include certainly the area of early event detection and surveillance, but also
functional activities in the context of supporting public health needs for
outbreak management, for urgent communications and for the administration of
countermeasures and response. These are pressing needs. We look forward to
working with this activity to have them advanced in due haste.

Thank you.

DR. LUMPKIN: Thank you. Microphone six.

MR. LAU: Hi. My name is Stephen Lau. I am with Price Waterhouse Coopers.
Whatever it is you come up with, I’m pretty sure we will be there to audit it.

Having said that, I am also a private citizen. I was sitting in the
confidentiality session yesterday. It was mentioned earlier that we didn’t have
any ethical concerns that came out of this. I would just like to pose a use
case, because we seem to be focused on what is the next step. But I am thinking
of the steps beyond that.

I will propose a use case. As we gather data for population health
purposes, if we were to identify a cancer cluster or perhaps certain
occupations or other types of behavior that may cause harm, as a consumer I
would like to think that somebody would eventually call me. I don’t know if it
is a provider, I don’t know if it is going to be the researchers who find the
information, but I would hope that in the interest of at least Stephen Lau,
somebody is going to tell me.

So I would just ask that we think about that question; once we have the
data and once we recognize that there is a potential risk that some mechanism
be created, where we can go back to the people who provided that data and bring
them in and say, this may be a problem.

That’s it.

DR. LUMPKIN: Thank you. Microphone three.

MS. THOMAS: Hi. My name is Michelle Thomas, and I am with Glaxo SmithKline
as an assistant director of novel opportunities assessment. I wanted to comment
on a remark that was made earlier today about the representation of the
biopharmaceutical industry in this initiative.

I think that it is absolutely critical that the biopharmaceutical
industry’s needs and contributions are considered as we move this initiative
forward. After all, we are about continuing to provide medicines and therapies
and products of value that continue to serve medical needs, and we see
tremendous opportunity in this NHII initiative.

So specifically, what we would like is a little bit of clarification. We
had a special interest group meeting last evening. We provided some of our
feedback through the clinical research area, but we would like the committee to
recommend specifically where we would be best served and where our priorities,
needs, requirements and contributions can be communicated and incorporated as
we move forward.

Thank you.

DR. LUMPKIN: I think in response to that, first and foremost — and maybe
this is because as you may have picked up on Wednesday, the Secretary can be
very forceful when he sets priorities and time frames. One that he has set is
to have a recommendation by the end of the year on e-prescribing. So we are
focused on that as a committee, and certainly there is an important role there.

But again, as we move forward, as with all the special interest groups,
there are two messages that ought to be very clear. One is that we are all in
this together. That means that we need to think of ways that we can work more
closely together. For instance, there are two major managed care organizations
on the West Coast, both of which are using the same vendor to set up an
electronic health record, but they haven’t set up means for them to communicate
between them as patients move from one location to another. There are all sorts
of reasons for that, but I think we have to get beyond that. That means within
industry, whether it be pharma, whether it be vendors or others, organizations
have to work together with the concept of interoperability.

The second is that we have to think about patients in the center. Then the
third is that within the organizations and across the organizations, how we can
move forward with our common agenda and set aside some things that may be more
proprietary, may be more related to the specific industry specialty, because if
we don’t all work together, this agenda will not progress.

So I think we will look forward, and thank you for the offer from pharma.
We will take you up on it. And the rest of you, too.

Let’s go to microphone two.

MR. KIRBY: Hi. My name is Dave Kirby. I am an active member with the North
Carolina Health Care Information and Communication Alliance, and also the
clinical informatics faculty at Duke University Medical Center, and a long-time
worker in privacy and security and the implementation level.

My recommendation is based on the specific case of the observation that you
can’t do what you don’t measure. I am struck by the relative lack of
measurement that we are doing about the effect and effectiveness and the effect
on perception of the public of our privacy policies. So I would like to
recommend that the NHII include some active measures to actually inspect the
effect and effectiveness of privacy policies, and spread that information
around in a way that people can use it in composing policies for their LHIIs in
operating the network.

DR. LUMPKIN: Thank you. Let’s go back to microphone three.

MS. LINZER: Hi. My name is Deborah Linzer, and I am in HRSA. David, thank
you for convening this really invigorating and energizing meeting. It has been
wonderful. I work in Maternal and Child Health, with children with special
health care needs.

I have four quick points that address a lot of the discussion that has
happened here, cross cutting, but to ratchet it down a little for those of you
to consider a little bit.

Number one, the Human Genome Project. Genetics is coming on as fast a track
as the work that is being done here. I would really encourage you to do some
thinking. There was some discussion about translating research into practice,
about the role of the NHII in helping to support that transition of information
into practice, as well as the new technologies in newborn screening and the
need for information infrastructure.

Number two. I said something with reference to this yesterday, encourage
all of you as we begin to speak about consumer-centric services, to look and
seek out the literature and practice on community-based culturally competent
family centered care that has been established through the years for children
with special health care needs and the disability community. At some point, as
we age we will all have some disability. There are lessons that have been hard
fought, learned, and are still being discussed and it is an important
discussion.

Third, when you talk about consumer representation, I would also look at
the models that have been established through the Ryan White Care Act, HIV
services, also special populations in terms of how you bring communities
together. We are not just talking about AHRQ, we are talking about
organizations like Family Voices, the Genetic Alliance, perhaps the March of
Dimes and other kinds of organizations, so you are representative across the
populations and across the life span as well.

I also wanted to say that there is a fabulous project that I am aware of,
and the project director is here, and I am forgetting her name, working with
migrant workers. It is a wonderful example of how to take a problem that is
happening out there in our communities, about how to deliver health care to a
very difficult population, and how technology is now making that happen. It is
just exhilarating to see. It is happening, it is up, it is going. So please
take a look at that.

Also, don’t forget the maternal and child health block grant that delivers
services to children and families in need, not only children with special
health care needs, but other children as well across our nation. It is a system
of care that needs to be addressed and factored into what we are doing here
today.

So thank you again.

DR. LUMPKIN: Thank you. Microphone two.

MS. KONO: Hi. My name is Koko Kono. I am a freelance writer, and also I
have a company and it is responsible for three employees. My concern is data
accessibility and confidentiality. I began self employed three years ago, and
at that time before I worked at a big company. I don’t have to think about
health care coverage. But now I am responsible for three employees. My concern
is, if insurance company access to my employees’ health condition through
electronic health record to assess health insurance premium, I am concerned
about this. As you know, health insurance premium is very expensive, usually
one family for self employed is about $1,000.

We have 43 million people uninsured population right now. The self employed
and small business owners, usually they have less than five people for
employees. We are very, very difficult to have health insurance coverage. We
possibly are to be an uninsured population. So my recommendation is that our
government establish a guideline to access in how to use data, who can access
to electronic health record, and ideally government would concern self employed
and also small business owners.

Thank you.

DR. LUMPKIN: Thank you. Microphone two.

MS. CHANG: Karen Chang from Purdue University School of Nursing. I am
excited with this conference. It is really very productive and energetic.

I’d like to follow up the first person’s speak about many points. I’d like
to see how we move forward. The way I envision is, it seems like we have a lot
of good information, but something wasn’t mentioned here, about building upon
last year’s work.

Yesterday I was in this consumer’s group. It was eye opening. It referred
to one of the handouts, starting with connecting something, I don’t know the
rest of the title, but David Lansky’s group.

DR. LUMPKIN: Connecting for Health.

MS. CHANG: Thank you. That is a very excellent report, and already
identified what is a necessary item for a PHR, personal health record, even
though I think a few more things can be built upon it. So I am glad that we can
— we need to refer to what has been done, build on top of it.

Another exciting thing is, whenever I need something they say, it is
available on the website, so assuming I can find that website. Another thing is
about this report with today’s summaries. I was told it would be loaded on the
website, which I am hoping to get it soon.

Another thing is, we have through these summaries of these eight groups —
I feel like we are so ambitious, trying to accomplish something. It seems the
opportunity is ripe, can be done, can be — can see it is the realization, or
measure the impact of our proposal in terms of NHII or LHII. But the thing is,
what is measured, if you delineate what to measure, then measure the facts,
measure the efficiency and measure the cost.

However, what to be measured seems like still a little fuzzy. For example,
we want population health, we want personal health, we want public health, and
all practice. So exactly what are the top priority, what must be done and what
should be done. It seems like that needs to be one step forward before
September.

Thank you.

DR. LUMPKIN: Thank you. Microphone four.

MR. GOLDSTEIN: Hi. I’m Jay Goldstein from Hackensack University Medical
Center. I just want to — the gentleman from the CDC suggested that we may want
to have some intermediate steps on the way to having a universal health record,
accessible anywhere, any time. So I would like to suggest that we try to create
a universal medication record as an earlier step, that we could prototype some
of the earlier issues with interoperability, privacy, et cetera.

DR. LUMPKIN: Thank you. Microphone six.

MR. WILLIAMS: Good morning. I’m Scott Williams. I am the executive director
of the Utah Department of Health. I am also a pediatrician, and I am the father
of three sons, which means I make frequent trips to the emergency room for
preventable injuries. Which reminds me of the gap between public health
practice and theory.

I just have two thoughts. The first one is, it seems that we are holding
the electronic health record to a standard that the paper health record has
never been held to. I think that is a good thing because we should be
advancing, but I also think that American health care providers have helped,
despite the patient safety concerns and the lack of delivering necessary care
in every instance, American health care has helped far, far, far more people
than it has hurt, using a fairly rudimentary record keeping system.

So I guess what I would like to see happen is some attention to what are
the necessary levels of interoperability that we need to make the record better
than we have now, and good enough rather than perfect. I worry that we are
trying to create perfection instead of improving what we are working with now.

I have practiced with underserved inner city populations for 20 years, so
data sharing is really important to me, because my patients go to a lot of
different places for care. But I can’t wait as long as it seems like it might
take to start sharing information. When I see two pieces of paper, and one says
WBC and one says white blood cell count, I know what those two things mean,
even though those papers aren’t standardized with each other.

So just a request to pay some attention to what level of interoperability
is really needed for data sharing to occur that benefits the clinician and
patient.

The second thing is a process issue. As one of the co-leaders of the
population health group — and we had a wonderful group, and I want to thank
Marty for his presentation — I think our group would agree that we would be
disheartened if these recommendations didn’t go anywhere. We would be equally
disheartened if they were taken at face value, given the limited amount of time
we had to create them. So I am hoping there is some sort of validation process
that occurs at least for our groups, but that doesn’t take too long to get them
put into place.

Then finally, it was ironic to me yesterday that we were talking about
developing highly sophisticated electronic medical records using blue dots on
pieces of white paper, pasted on the wall. I wonder if this process could be
altered a little bit from here on to employ group process technology that would
allow broader participation, not only in this room, but for the people who
can’t be in this room, and that our ability to implement that as a group may be
able to inform us about the velocity with which we are able to implement
electronic medical records in the health care system.

DR. LUMPKIN: I think that is an excellent recommendation, if we can ever
get an interoperability standard for the group process software. We would be in
good shape. Microphone six.

DR. SCHNEIDER: A very tough act to follow. I am also a pediatrician. My
general topic is on research here. I am one of those folks who doesn’t have a
VCR, and my DVD doesn’t blink 12 o’clock, it has got the exact time. However,
having said that, I have made more medical errors using EMRs in my past one
year and a half of using them, at least that I am aware of, than I have made in
my entire medical career. These are errors fostered by poor design and also use
of multiple interfaces, with failure to have enough time to master any of them.

I work in a large city in Houston, and I go to five different clinical care
sites, where we use seven different electronic medical records. The airline
industry learned a long time ago that you don’t put a pilot in a 737 one day, a
747 the next day, and an A300 the next day. That is a recipe for disaster, but
yet that is what I am doing, and it is replicated in city upon city throughout
the country.

The other piece that contributes to this is poor implementation with regard
to usability, where for example I have one computer for an entire clinic, and
so when I rush out I have got the wrong patient record loaded up, and I can’t
tell the difference, and I order on the wrong patient.

I hope I am not the only one with this problem. I think there are others.
On our listserve for the American Academy of Pediatrics, we have got folks who
have ‘fessed up to a bunch of these things. The University of Cincinnati gave a
presentation about this that was part of this subject. What I would encourage
the DHHS and the committee and really everyone is to support research into how
the EHR and LHII contribute in some ways to medical errors and how we can avoid
them, especially in this decade of transition.

Thank you very much.

DR. LUMPKIN: Thank you. Next, microphone four.

DR. WIEDER: Hi. I’m Mark Wieder from University of Pennsylvania. We have
heard a little bit about looking for measures of success of this program. One
of the things that I would like to propose to everyone is, we all know that the
To Err is Human report is an oft-quoted document, where between 44,000 and
98,000 people die every year. A lot has been said about the accuracy and wide
range of those numbers.

What might be under appreciated is, already that is a five year old report,
and you wonder how many things from five years ago are as accurate today as
they were five years ago. But worse than that, it is a five year old report
that was largely based on two articles that were written in the early 1990s,
that were based on data from the 1980s. That is not to say it is highly
inaccurate; it is just to say that this data is very hard to come by.

I think we will have a sense of how successful we are when we can no longer
quote that report, we can quote a new report that is based on data from
yesterday or last year. I think in achieving that goal, we need to leverage
some of the existing sources of national data that already exist.

Now, how many people here are users of Medicare claims data? I can assure
you, there are Medicare societies where everyone in the room would raise their
hand. When Dr. McClellan was talking about moving Medicare into the 21st
century, I hope he includes the notion of the manner in which data is
disseminated to researchers to go from this IBM 3480 magnetic tape in Epsidec
format to something more current in CD or DVD that is probably much cheaper to
create, and certainly much cheaper for us to process.

Secondly, organizations like the AHRQ and the CDC have national data
collection efforts, which are okay, but I think would benefit a lot from some
funding increases, so they can do a better job with resources like HCUP and the
national inventory medical care survey and the MEPS and things of that sort.

So that is the kind of recommendations that I would like to see happen.
Thank you very much.

DR. LUMPKIN: Thank you. Microphone three.

MS. THOMAS: Hi, it is Michelle Thomas again, but this time I’d like to
speak as the clinical data interchange standard consortium or CDISC.

PARTICIPANT: — with every pair encounter electronically submitted, that we
could see a wide variety of private activities that would seek to assist
consumers, assist providers, assist other personnel in a variety of appropriate
uses of that data, appropriate transmission of that data, that we would unleash
the kind of marketplace activities that would lead us more rapidly towards the
goal of a consumer EHR for every citizen.

DR. LUMPKIN: Thank you. Microphone four.

MS. ADAMS: Laura Adams, Rhode Island Quality Institute and long-time
faculty member of the Institute for Health Care Improvement in Boston.

There are just two thoughts that I would like to offer for the committee
and for everyone in this room. Everything I have heard over the course of the
last two days has to do with enormous hope and great vision. We all leave here
extremely energized. There are two thoughts about sustaining that hope and
achieving that vision that I would just like to mention.

One is that so much of this as we know is dependent upon funding. I would
just like to keep this in mind for everybody that has the ability to influence
funding, that has the ability to invest or somehow direct funding to this. Keep
in mind that we are already spending the money necessary to buy this system. We
are just purchasing ways with it right now. Now it is a matter of redirecting
that money to buy the systems that we need. So just keep in mind that we are
already spending the money. The sooner we spend it, the sooner we are going to
see a return on that investment.

I think the second comment that I would like to make is that for many of
us, the greatest hope that we have coming out of this is that we will see some
of this in our lifetime. We are very, very enthused and excited and energized.
As we leave the conference today, we have made many new friends, new
acquaintances, and a sense of common vision here. However, we all know that
when we get back to the office on Monday, there is the complexity, there are
the distractions. We call it burning up on re-entry.

When we all experience that burn-up on re-entry, it is so important that we
sustain what we felt here today. To do that, I would just like to offer a quote
by Don Berwick that has really helped me through times when you start to feel
like this is pushing a boulder uphill, it is just too heavy. Don Berwick said,
I have heard it said by cynics that the quality of medical care would be far
better, and the hazards far fewer, if we — those of us in health care — like
pilots were passengers in our own airplanes. Just keep in mind that for all of
you that have a child, a husband, a wife, a mother or father in this health
care system, we are all passengers in this airplane.

DR. LUMPKIN: Thank you. Microphone six.

MR. LEARY: Good morning. Tom Leary, Director of Federal Affairs for HIMSS.
I want to take the opportunity to recognize two of our HIMSS individual members
here in the room today, Steve Steindel from CDC and Jeff Blair from Medical
Records Institute, and the efforts that they have put forth for our NHII survey
that was released this past Wednesday.

This committee was briefed on our first effort last fall, and a more
comprehensive effort was released this past Wednesday. Two things that we have
seen are, one, there is an increase in awareness amongst the respondents on
what an NHII is, and secondly, as is reflected in the discussion throughout
these last three days, the barriers to the lack of agreed-upon policies
regarding access to patient data and the lack of standards to support data
sharing are the two largest barriers that our respondents have identified.

So I just wanted to thank the folks that are in the room, and make sure
that this was entered into the record. Thank you.

DR. LUMPKIN: Thank you. Microphone three.

MS. FORCAT: I am Laurie Reid Forcat. I co-chair ASTM’s security and privacy
standards, and I am vice convener for ISO health informatics security and
privacy standards. We do have a number of standards that have been developed. I
would encourage the group and stakeholders to take a look at them. If they are
insufficient, please feed back through these organizations, comment,
participate, help develop some standards that will support the work effort and
make sure that both of those groups can help move the NHII forward.

DR. LUMPKIN: Thank you. We are actually out of time, but I am going to take
the three people at the microphone, and then we will move to the next item on
the agenda. Starting with microphone number five.

PARTICIPANT: I am with the Department of Health Science Informatics at
Johns Hopkins University. As we talk about interoperability, it seems very odd
to me that we are not taking our cues from the past. In the late ’60s,
government, research institutions and military had the exact same issue, and
eventually the problem was resolved by having government implement the
standards which eventually became the Internet. If we wish to wait for industry
to devise its own standards for interoperability, essentially we are going to
be waiting a very long time, the same way that it took Microsoft nearly 15
years to become the de facto standard for a word processor. We are going to
have to wait nearly as long for industry to battle it out until a standard can
be defined.

So we really have to take our cue from government as to how these standards
will work, and then industry can develop around the standards and thusly we
will have an interoperable system.

DR. LUMPKIN: Thank you. Microphone four.

MS. MOLINA: Synthia Molina, CEO of Alternative Link, the developers of ABC
codes. I just want to applaud the Administration for what I think is a
remarkable highlighting of the importance of the consumer in this equation, and
a shift in vocabulary that in my view is not a subtle shift from a
patient-centric or a physician-centric system to a consumer-centric system. It
has been very encouraging to me as a consumer and someone very interested in
the advancement of health care to see that shift. I think we will see
remarkable and very unexpected outcomes as a result of it, some of which I
think were beautifully highlighted by the research team who got up and spoke
about the importance of getting metrics around things that affect health and
around issues of prevention and wellness, as well as issues of medical care.

So my congratulations to the committee and to the Administration for your
work on that shift.

DR. LUMPKIN: Thank you. Microphone three.

DR. NAVE: My name is Dennis Nave. I am a geriatric psychiatrist, professor
of geriatric psychiatry at Louisiana State University. I’d like to thank
everyone who put this program together. It has been an excellent program.

I also thank you for letting me have the opportunity to take the final shot
here. I think this opportunity is to bring out and point to a number of things
that are sub-categories perhaps of larger things that we have done today, but
things that we are going to look at in the coming future, that are going to be
really important in the area of privacy and security.

I want to remind and want to encourage everybody that when it comes time to
write those, we need to have the input of psychiatrists, mental health
professionals and consumers, because this sub-area of privacy and security is
going to require some special attention. It is not going to be easy to handle,
but input from the mental health professionals and the consumers, who are
people who consume and are treated for mental illness, need to be part of that
program.

The second aspect is, the biggest resistance I see amongst the doctors —
in Louisiana at least — is front-end cost in getting into this. I know we have
put ideas for incentives forward for this. By the same thing, to get
psychiatrists, one of the things that you need to do is to do away with the
Medicare psychiatric outpatient discount. For psychiatrists to buy into this
system, for outpatient, when we get reimbursed 50 percent, where all other
specialties get reimbursed 80 percent, it is going to be a hard sell to get
people to be willing to go this far in situations where our reimbursement was
less. You would find it a lot easier if that were changed, to say nothing of
the issue of our population aging, and better access to care for the aging.

Thank you.

DR. LUMPKIN: Thank you. Although when you got up to speak, and you
commented on what psychiatrists could add to the process, I thought there was
one that you left off, which is, when you get a group of people in a room, we
may need a psychiatrist in order to be able to get everything together.

I’d like to thank the presenters and people who commented. I think this has
been a very fruitful discussion for us.

Before I introduce the next speaker, I want to take care of a few
housekeeping things. First, I wanted to clarify what happens next. Well, there
are short next and long next, but the long next is that the reports that we had
today, the comments, all those materials, as with everything that we do within
the National Committee on Vital and Health Statistics, will go up on our
website as soon as we get them transcribed. So there will not be a delay in
getting this available to add to the debate. We will officially transmit them
to the Department at our next meeting, but that won’t delay them going up on
our website.

So again, I want to thank everyone, because this will be a part of what is
being developed. Obviously the sense of urgency has been adopted within the
Department.

(Remarks off the record regarding post-luncheon meeting arrangements.)

I’m going to tell you a little bit of a story before I introduce the next
speaker. It is not a funny story, though. In 2001 in November, this committee
developed a report, as I mentioned, Information for Health, on the National
Health Information Infrastructure. It was quite an exciting process. We had
conducted hearings across the country.

After we completed the report, it went out, and a number of you thought
that it was a good report, but within the Department, there wasn’t a lot of
response. In fact, six months went by, and there still wasn’t much response. We
tried to set up meetings with various staffs within the Department at the
director level, and none of those happened.

Then the Secretary commissioned the Institute of Medicine to have a
meeting. It was based upon a report that the Institute of Medicine prepared on
the commission called Rapid Advances in Health Care. Don Dettmer — I don’t
know if he is here, but he was on that committee. One of those provisions of
that report was on information technology. At a hearing, which was a small
invitational meeting at the Institute of Medicine, I sat at a table with Don
Dettmer and Molly Coy, and we talked to the Secretary about the issue of
information technology, and it was like a light bulb went on.

Many times, we are going to look back and say what was the tipping point in
which we looked at the rapid adoption of health information technology, and I
would argue that meeting in November of 2002 at the Institute of Medicine, that
that was the tipping point. When the Secretary of the Department of Health and
Human Services began to raise the issue of health information technology within
the Department, all of a sudden our report and the issues that we raised began
to get attention with the Department directors.

This whole concept was raised to a second level and a higher level, and I’m
sure the Secretary was the one who drove this, when the President himself came
out and made an announcement and a commitment to health information technology.

Our report when we drew it up had a recommendation in there that we thought
would go nowhere. But we said, if we are really going to move this issue
forward, that there needed to be a national coordinator who reported directly
to the Secretary. Our staff of the committee in the Department, many of them
said, don’t put that in there, because then that will get the various agencies
and the Health and Human Services saying who is that going to be, and I don’t
want to play if it is not going to be our agency.

As you know, not too long ago, this was adopted in an executive order by
the President. The first individual, when they began to do the search, and many
of us who have known David Brailer for a number of years, when we finally heard
the announcement, we said, now, that makes sense. It isn’t often when you deal
with government, and I worked in government for 17 years, that you make an
announcement, and people actually say, that makes sense.

So we are really pleased and honored to have David, who has worked in this
field, who has been a pioneer, and once again is a pioneer as the first
coordinator of national health information technology, to present the closing
comments. David.

Agenda Item: Closing Remarks: 2004 Cornerstones for
Electronic Health Care Conference

DR. BRAINER: Thanks, John and members of the committee, all the other
attendees. I guess I should say thanks for not making a recommendation that the
office be disbanded, at least maybe you won’t, but given the credibility of the
NCVHS, I’m afraid they might pay attention to it.

We have gone through a journey in the past three days. I think it has been
three days. It seems like a year, doesn’t it? We hit the soaring heights on
Wednesday. We heard every agency head who is involved with health information
technology as a primary part of the portfolio say, yes, this is our plan. You
heard many leaders from industry, health care, from consumers, from payors, you
know the whole list and I won’t recite it, say we are on board and we are going
to go someplace.

We then hit the real issues yesterday. Now we don’t have any excuses,
people are on board, what are we going to do? There are many barriers. We live
with this. My whole career has been around this, many of yours. I think the
recommendations that have come out today have found the balance point, which
is, how do we start navigating this, what is the short list of things that we
need to focus on and the big picture things that we always want to make sure
that we are mindful of. This discussion is incredibly helpful to me. In fact, I
have been making notes back and forth, constantly checking things that are
being said against not only what is in the framework that you saw, but the much
more detailed analysis that we did to support that framework.

Remember, the 12 strategies that we put forward started with probably over
30 strategies, and each of them had significant discussion about what are the
underpinnings of this and what does this mean. They were not casually
determined. I think we found in general good alignment with what I have heard
here and with what we were thinking, which is either good or bad. It could be
good that we do see this the same way; it could be bad by the old adage, that
when experts agree, all you know is that experts agree, and it doesn’t mean
anything. I think it is the former, I think we do see some commonality. We are
eager to hear the recommendations as they are formally processed and formally
thought through. Sooner is better than later to the extent you can. I know the
Department is working the committee very hard with many other things. I already
got a call from the Secretary this morning asking me what I was going to do
this afternoon.

So to that, I am very, very optimistic. I am normally that way, I guess,
but this makes me incredibly excited, because I see a tone here of pragmatism,
that we do have real work to do, but there are things that we can do.

I am going to be looking for what role we play. I will say this in two
ways. First is what role my office plays. You can’t define coordination very
well, because by definition we work with the agencies to accomplish things. We
don’t necessarily do, although we have the authority to do things that people
want. I think the question that I am asking a lot of the agencies, I’m going to
ask the industry, is let’s make sure that we know who is supposed to do what.
That is something we will help with.

But there is a much broader question here, which is, what is the role of
government. One of the things that has been a subtext of all the comments that
I have heard for the past three days is, not disagreement, but certainly a
range of opinions about the role of government. The conclusion I have from
listening today that I would like to get your reaction to is, I think it
depends on the topic.

When we are talking about financing, given the incredibly large footprint
of the federal government in just buying care, and paying for care. It has a
different role than standards, and it has a different role. We want to have a
very significant dialogue about the theory of government here. I want to be
very careful that we don’t overstep and that we don’t take bold enough steps. I
do not want to see big pieces of this controlled by the government, but I want
to see this get done. So this tone is going to be very important, and this
might be a dialogue that we could have with some of you in some way, and we are
thinking about this very much. But it is really an important subtext here, that
we make sure that we play the appropriate catalytic role that will make sure
that we move forward, and that we do so in a way that is sustainable across the
entire industry, and creates its own support as opposed to a dependency.

So this is incredibly exciting to me for this reason. I do want you to know
that on Monday, 8 o’clock, my staff will be working on what we are going to do
next. We are going to be working on very pragmatic steps. We are not going to
be writing a lot of intelligent, thoughtful papers. Some of you know i have a
penchant for writing papers. I don’t know if they are thoughtful and
intelligent, but they are long. We are not going to do that. We are going to
focus on some very tangible things that are obvious from this discussion, and
we will be in dialogue with many of you.

I’m not sure which of the things we will be pushing for, we will move fast,
and which will get caught up. That is why we are going to push on more things
than what we can do at any point in time. I want you to do the same thing. This
is now about action, it is about movement. If we take the opportunity that we
have been given this week and don’t take advantage of it, we will have lost an
opportunity. It is a perishable good. So I ask you to lead the language of
action, and to move, and we will do this together.

I think it should be clear to you. I was out this morning and most of
yesterday afternoon. I have to be out this afternoon also with meetings with a
variety of other entities, but what has happened here has rocked the world.
There has been coverage on this in newspapers all over the United States and in
Europe and in Japan. There are numerous Congressmen in committees talking about
this discussion in a way that they never have. The Secretary has been on the
phone all day yesterday and today with people, talking about what has happened
here. This has hit the White House. It is very clear to them what has happened
here, and the importance of this. I think we just need to step back and say
something important did happen, but we have to take advantage of it and take
the next step, and I know we will do that. I know we will do that.

So let me say a few final comments. One, thank you, thank you, thank you.
You all have done incredibly good work. This is far beyond my expectations.
Some of my staff who have worked with me for several years through various
journeys know that I rarely am impressed with anything that people do. It is
true. They also know that I am blown away by what happened here. It is because
of what everyone did. I just want to say again, thank you, because you are the
leaders. You are the people who are going to make this happen. I thank you for
the opportunity to serve you and to be part of this.

Let me also say thank you to this committee. I know what work you have
done, and we have got lots more to do, and we are going to cooperate very much
in doing that because of the importance of this dialogue. We are going to be
very focused on results, we know, and this group is already way out ahead of
that. I think in a lot of ways I am pulling in behind you.

I also just wanted to say thank you to all of the people that worked on
this meeting, the experts, reporters, co-leads, facilitators. Could you all
stand up? It is probably the whole room, all the people that put together
papers and the materials. Thank you. I also want to thank the staff of the
office of the national coordinator again. Could you all stand? I just want to
give a special thanks to Missy. I have enjoyed working for Missy for a long
time.

Finally, let me say that when we convene again — and the next time I
expect us to convene will be in topical areas. After we go back and refine the
strategies based on this input, we are not going to have broad brushes. We are
going to drill down on some of these things, and we are going to get different
groups together, depending on the topic and the goal. We will see you there.
But I do want us all to remember that the next time that we do get together as
a large group, I want a lot of the agenda to be about what we did, not about
what we are going to do. I think that is the transition point.

I have a goal of ending meetings like this because of the inevitability and
the reality of it. If we think about it that way, that the next time we are
going to get together, we are going to show all of our successes, and we will
have a few other things to talk about in the future, I think we can stay on
track with the agenda that we have got.

With that, let me say again, thank you for your very hard work, your
intelligence and your passion that has shaped an agenda that is now center
stage in America.

This meeting is now officially ended. Thank you.

(The meeting recessed for lunch at 1:10 p.m.)


A F T E R N
O O N S E S S I
O N

DR. LUMPKIN: We are going to begin the afternoon session. We are going to
go around the table and do introductions, as is our usual practice. This
session, I believe, is going out over the Internet, so we are going to start
off with introductions. My name is John Lumpkin. I am chair of the NHII work
group, and also senior vice president at Robert Wood Johnson Foundation.

So we will go around the table and start off with Steve.

DR. STEINDEL: I am Steve Steindel, Centers for Disease Control and
Prevention, staff to the work group and liaison to the full committee.

DR. YASNOFF: Bill Yasnoff, HHS, and I am the HHS Office of the Secretary
liaison to the work group.

DR. STEUERLE: I am Gene Steuerle from the Urban Institute, and I am a
member of the committee and also of the NHII subcommittee.

DR. CARR: I am Justine Carr from Beth Israel Deaconess Medical Center in
Boston and member of the full committee.

DR. HOUSTON: I’m John Houston with the University of Pittsburgh Medical
Center. I am a member of the committee as well as this working group.

DR. ORTIZ: I am Eduardo Ortiz, staff to the working group. Most recently I
was with the Agency for Health Care Research and Quality, but now I am the
associate chief of staff for informatics at the Washington, D.C. VA Medical
Center.

MS. WILLIAMSON: Michelle Williamson, National Center for Health Statistics,
CDC, and staff to the NHII work group.

MS. WARREN: Judy Warren, University of Kansas School of Nursing and member
of the committee.

DR. VIGILANTE: Kevin Vigilante, principal at Booz Allen Hamilton and member
of the committee, and the NHII working group.

MR. BLAIR: Jeff Blair, Medical Records Institute, member of the committee.

DR. HUFF: Stan Huff with Intermountain Health Care and University of Utah
in Salt Lake City. I would need to recuse myself from talking about HL-7 or
LOINC or ICD-10 PCS. My usual list.

DR. COHN: I’m Simon Cohn. I am National Director for Health Information
Policy for Kaiser Permanente, and a member of the work group and committee.

DR. DEERING: Mary Jo Deering from the National Cancer Institute and lead
staff to the NHII work group.

DR. GREENBERG: Marjorie Greenberg, National Center for Health Statistics,
CDC, and Executive Secretary to the committee.

MS. POKER: I am Anna Poker from AHRQ, the Centers for Quality Improvement
and Patient Safety, and I am staff lead on the quality group and I am a staff
member of NHII.

DR. LUMPKIN: This is a continuation of our meeting earlier today. The group
from the audience is a little bit smaller than it was this morning. Thank you,
for those of you who decided to stay over.

The first item on our agenda is a report on Connecting for Health. After
that we will have some discussion of what we heard this morning, as well as
what we are going to hear this afternoon. Our goal is, after we are done today,
to set the agenda for the NHII working group on those areas where we believe we
can add some value to this rapidly accelerating process of adoption of
connectivity in health information technology.

So our first speaker — and we have one invitation, and she didn’t feel
comfortable, so she brought the whole crew — is Carol Diamond, who is the
chairperson of the Connecting for Health public-private collaborative.

Agenda Item: Presentation of Connecting for Health
Road Map Report

DR. DIAMOND: Thank you. I am Carol Diamond. I am with the Markle
Foundation. I am here with lots of people who participated in Connecting for
Health, and more who participated in our initiative who are not here today,
that needs to be acknowledged. The reason they are all here is because it is
their work. I just coordinate it and help it happen. I think without them and
without the hard work of everyone who has been involved in Connecting for
Health, we could not have pulled this report together as quickly as we did.

I will just say to the committee, I know many of the committee members are
familiar with Connecting for Health. John Lumpkin is part of the leadership of
the steering group along with Herb Partisef, who is the CEO of hypothesis
Presbyterian, and Dan Garrett of Computer Sciences Corporation.

I will just say to the committee that Connecting for Health is an
initiative that is funded and operated by the Markle Foundation, with
additional support and funding from the Robert Wood Johnson Foundation. We have
been running the initiative since June of 2002, although this phase of the work
on the road map did not begin until January of this year.

Let me say a few words about why we did this road map and what the impetus
was for it. Our steering group, as you can see in the report where members are
listed, are some of the nation’s foremost leaders in health care, expressed a
growing impatience with this agenda, and felt that we really needed an action
plan for moving forward. So we did our best to try to pull together an action
plan in this road map that represents consensus, but it is not consensus that
we started with. As those of you that read the report know, we started with
things that we called forks in the road in several areas. We wanted to try to
get the recommendations to be things that people felt were the right near-term
steps.

Several people here are going to present, and I will just do a brief
overview of the way the road map is laid out, and then we will try and walk
through as much of the content as we can.

There were three overarching themes for which there was a lot of agreement
in our group. One was that we needed to have a clear and understandable message
to the public about this agenda, that there was still a gap in their knowledge
about the importance of IT in health care and what it could do for their health
care. We needed to consider the needs and the changing roles of patients and
their families in the health care system as we thought about IT. The system
needed to be designed for privacy and security from the front end. Those themes
have inculcated all the other recommendations. They have made up the fabric of
the road map.

Then we have some forks in the road. The road map started with interviews
of all of our steering group members and their ideas for what needed to be done
and what areas needed to be focused on. There were several areas which
everybody agreed were important. We needed to talk about infrastructure and
standards and applications, but for which the near-term actions were not clear.
People had different ideas about what could be done in the near term, and this
report does represent our work, the work of the people up here with me today,
the very hard work of trying to come out with a set of recommendations that
should represent for folks the near-term, one to three year kinds of things
that the group felt were possible and doable and were the right next steps.

I do want to acknowledge several of the members up here on the technical
expert panel who helped put together the technical recommendations. Several are
up here with me, several are not. I just want to acknowledge their
contributions and input along the way.

With that, I will turn it over to Mark, and we will get started.

MR. OVERHAGE: Thank you, Carol. I am Mark Overhage from the Regenstrief
Institute in Indianapolis. I am just going to review briefly the three primary
recommendations that Connecting for Health generated in terms of
infrastructure.

The first is that it is very important that we have interconnection between
health care applications. There is a lot of discussion about EHR versus the
highway. We think it is very important that both evolve simultaneously, because
they reinforce and support each other.

In order to move forward the most rapidly, we think that a health
information infrastructure that is a network of networks, if you will — and
I’ll show you a cartoon in a moment — built on the Internet that safeguards
privacy, leverages top-down, bottom-up approaches, and is incremental in
nature, based on the decentralized federated model, is the most likely path to
success.

The networks shouldn’t contain a central repository. I think that is a very
strong statement. It was recognized that that was such a lightening rod, that
that was not a direction that we thought was successful to go. We will also
talk a little bit more about the infrastructure recommendations in a moment.

The second thing I want to talk a little bit about are standards and the
importance and criticality of those for moving forward. All of the standards
that are needed probably exist today, but we think there is an important step
that has to happen, which is the selection, bundling of those together — some
people refer to those as profiles — along with implementation guides and other
tools that make them more plug and play. It is too hard today to pick them all
out and put them together and make them work, so they have to be combined in a
coordinated fashion in order to move forward.

When adopting these clinical information standards, it is important that we
strike the proper balance between how much structure we require, while
accommodating as much structure as the system will bear, the physician and
provider system I am talking about in particular.

Finally, methodologies to test interoperability must be based on use cases
that involve the interoperation of these systems at different levels of
sophistication. In other words, you want a system to be able to take advantage
of all the data that are available to it, without requiring that every system
be that sophisticated, because we need an incremental approach in order to
allow each health care participant to evolve at a different rate. We can’t shut
down the health care system on Friday and start it back up on Monday with
everybody retooled. For that purpose, we will have to give serious
consideration to the benefits of the HL-7 clinical document architecture as the
tool for moving that forward.

The cartoon that is on the screen was designed with major design criteria
that a hospital CEO could understand. So it really abstracts out a lot of the
details, but it actually tells a fairly good story about how we imagine the
architecture and standards fit together to make this system work. I’m not going
to describe it due to the time constraints here, but Wes is going to talk a
little bit about the common framework or set of pieces that have to exist in
order to support that.

Thank you.

DR. RISHEL: Hi. I’m Wes Rishel, immediate past chair of HL-7, and a vice
president of research and director for Gartner.

Mark made a point that there is a co-evolution here of applications and
standards of interoperability going together. I think it is important to
recognize that there will never be an application, never be an EHR. There will
be different products at different levels of sophistication and capability,
heterogeneously across even the smallest network. So the architecture and
standards approach associated with interoperability has to take into account
that variability.

Among the kinds of variability, there will be those EHRs that are highly
sophisticated and capable of capturing all kinds of wonderfully detailed
structured data, those that are less sophisticated but far easier to implement
in small practices, and those that are pieces of an EHR, such as an
e-prescribing only application, or something like that.

As we move towards a standards approach to interconnecting these
applications, we could pick one of two extremes. We could say only those that
are highly sophisticated could participate, or we will limit interoperation to
a common denominator, so that many kinds of EHRs can participate. But we
advocate another solution, which is to architect the way the standards are
applied, so that the data is provided with the best capability of the system
that sends it, and interpreted with the best capability of the one that
receives it. So any given sharing of information in the network accomplishes
the best that the particular systems that are involved can provide.

We have mentioned the various provisions beyond simply incentives that it
takes to accelerate EHR adoption among the providers. These include measures to
support the physicians, most of whom are not wonderful businessmen in making
the decisions that are associated with selecting at EHR, and dealing with what
they perceive correctly as a significant risk in that decision.

We recommend the use of a certification approach for facilitating that
decision. In other words, the fundamental issue here is that incentives are not
enough, that there needs to be intellectual support to the physicians in order
to make EHR happen.

In the group we had considerable debate about this issue of incremental
applications. They are almost a train that can’t be stopped at this point,
given the Medicare Modernization Act and so forth, but on the other hand, do
they represent dead-end alleys to the greater good of sharing of information.
Our recommendation is that the approaches to supporting a choice of those EHRs
avoid dead ends, either by advocating systems that are expandable, even if they
are limited in functionality to start with, or having a standard by which the
information from a product that has limited functionality can be carried
forward in its entirety to another product that might be more comprehensive. So
even if a physician needs to invest in a different system, they aren’t giving
up that body of data that they have built up in the use of their previous
system.

The issue of how to go about certifying the functionality of the electronic
health records is a critical one. The issues largely rely around governance. If
you can look at the governance of various certification-like organizations,
whether they are certifying products or accrediting how products are used in a
given situation or something like that, they cannot have the fully open process
that is associated with the standards development organization. By nature they
are designed to give the voice to the minority, and certification organizations
probably need a little more streamlined decision making process.

On the other hand, they have to be entirely representative of the
stakeholder groups who are relying upon them in their governance. Otherwise
they will be ignored. So establishing the correct governance for certification
organizations is a critical part of establishing certification and
functionality.

I think we have said that there are a lot of standards out there and they
are all great. The difficulty in using them is that it is a simultaneous
equation in multiple variables, in how to use them. A solution that works for
true interoperability involves solutions to a bunch of different standards
questions all at the same time. That is what we call a profile.

We think when it comes to interoperation through information exchange, the
mechanics of how to go about certifying a product or accrediting an
implementation of a product benefit by the Internet. So how you go about
gathering information and so forth can be accomplished a lot more over the
Internet than it can simply by certifying the functionality of a product. So we
would hope that the certification approach for interoperability would take
advantage of that thing.

The second point we made — I presaged in my comments — the standards need
to be evolutionary. That is to say, in order to get something accomplished in a
few years, we may not get to all of the wonderful goals that are in Dr.
Brailer’s framework, with the initial set of standards. But if our approach
makes certain to vendors and purchasers that in future years other standards
are coming into force and what they are, then it allows the vendor community to
deal with raising the bar in an orderly way during their software development
than in the somewhat disconnected way that comes in last-minute reactions to
sudden regulations.

We say to some extent, all standards are available. In fact, there are
holes that have to be plugged over time. I can assure that you all of the SDOs
have a tremendous collection of volunteers ready to work on these problems. In
fact, we joke at HL-7 that we coach them on how to lie to their boss about how
much volunteer time they are putting in on HL-7. But what we have in the
standards group is a situation where the enthusiasm and ambition of the
volunteers exceeds their bandwidth.

What we need to do is to focus the standards organizations on those areas
that are most immediately prioritized with this evolution that is associated
with electronic health records. We have some experience with what the VA has
done over the years and with the electronic health record functional trial use,
and what are the ways to take a voluntary organization and focus its work in
specific areas. We would like to see that continue and be used as a policy
management approach to standards organizations.

Next person.

DR. HALAMKA: Good afternoon. I am John Halamka, the chief information
officer of Beth Israel Deaconess Medical Center in Boston, the CAO of Harvard
Medical School and the chairman of the New England Health EDI Network.

We have heard from this architecture group that there is this notion of
finding out who the patient is and then getting their information. So what this
tells us is not that we need a central single identifier; we need a process for
identifying the patient. What I will argue is that in fact, a health identifier
uniquely issued to each individual is a very bad idea.

A bit of cabdriver wisdom. I am a strong believer in cabdriver wisdom. I
was in the UK recently, and I asked the cabdriver, do you know your national
health identifier, and his answer was, not only do I not know it, I wouldn’t
know how to find out my national identifier.

So then I lectured at a very large hospital in Cambridge, and I said, can
you look up the national health identifier? They said, absolutely. If you know
who the patient is, you can find their national health identifier. It is not a
key field. This illustrates one of the major problems with the national health
identifier. All of our IT systems in this country don’t have a field called
national health identifier. In fact, I run medi-tech systems in five of my
hospitals with a ten-digit identification for medical record number, and you
can thus guarantee that I would have to rip out every information system that I
have in order to support a longer identifier. It is very challenging.

So we put together this notion of, we need a centralized method for getting
to patient identity. Here are the principles we adopted.

It should be decentralized, very much like the Internet has decentralized
the domain naming system. I can type in a web address, it figures out where the
server is.

Ultimately, we think that data quality has to be maintained locally. I have
three FTEs dedicated simply to going through our various indices of patients
and assuring that they are appropriately linked. Our nine million patient
records, about a thousand identifiers are ambiguous in any one given day, and
humans do have to fix that, despite our best efforts.

It should be federated, with the idea of local good data integrity linked
together in a federated model, again much similar to the Internet, without a
central published health ID. As an example, one of my IDs is
Jhalamka@hms.harvard.edu, and that is a valid ID. So is Jhalamka@hotmail.com.
As soon as you issue a valid health identifier centrally, you immediately have
multiple of them. So building an architecture that supports the idea of each
individual having multiple external IDs linked together would get us off the
dime. One of the things that we have heard from this conference is, we have to
do something that is actionable. Waiting for a national health identifier is
simply going to slow our progress.

We believe it would be bottom up and top down, meaning national standards
for the exchange of patient identity information, conceivably a national
pointer system, but ultimately localities and regions can build interoperable
EMPIs and contribute to that national effort.

We also believe that development should be decoupled, meaning that there is
no reason why a doctor’s office that has a practice management system that is
capable of identifying a patient can’t participate, even if they don’t have an
electronic health record. In fact, what they can forward to the central
directory is, we have information about this patient, and to find out, call our
phone number, here it is. Hence, that would mean that we could do a national
query. It might not be an electronic result beyond a series of pointers, some
of which may be leading to manual methods of data exchange. Some information is
better than no information, and getting started is important to us all.

I can’t emphasize enough the rip and replace factor. We want to keep our
existing IT systems in place, and any impact on our IT agenda should be
minimal. We should be able to leverage what we already have. And of course,
building good audit trails around this centrally and locally is important.

Concluding on why the national health identifier would be a bad idea, it is
just another piece of data. Three percent of the social security numbers in my
care group data systems are completely incorrect. That is because of
transposition, falsification, people just have poor memories. It is not going
to be any better for a national health identifier. It will be a long and
expensive process to implement such a national ID, and our political culture is
certainly at this point, both at the patient level and at the policy level
nationally, not amenable to a national health identifier.

You will hear from Peter next on why we also believe the threat of privacy
spills would be significantly worse with a national health identifier that
could be used for linking.

So in summary, you have seen the architecture model. Let’s build a central
mechanism that is standards based and distributed for identification of the
patient, and use that as pointers to distributed locally controlled data in a
network of networks.

DR. SWIRE: Greetings. My name is Peter Swire. I am a law professor now at
the Ohio State University. In 1999 and 2000, I was in the U.S. Office of
Management and Budget, where I was the White House coordinator for the HIPAA
privacy rule, during the proposed rule in ’99 and the final rule issued in
December of 2000.

Connecting for Health has asked me and asked a number of other privacy
experts, security experts, public interest folks of different sorts to be part
of the process. I am going to make five points fairly briefly in the couple of
minutes that I am speaking today.

The fist point is that there needs to be a patient-centered aspect to
whatever it is the NHII turns out to be. In this committee’s report from 2001,
it discussed the personal health dimension. That hasn’t been mentioned so much
in the last few minutes, but it certainly is a big part of Connecting for
Health’s efforts, having patients have access to their records, being able to
e-mail your doctor going forward, get your lab results in a handy way. These
ought to be part of what we all expect from the next generation of technology,
not all in the next two years, but over the next ten years. It will seem
increasingly strange to patients if they can’t get that kind of service from
the health e that they get from all the other sectors of their life.

A second point, and this is from having watched the debates in Washington
for quite some time now, is that privacy together with security is likely the
single greatest roadblock to public acceptance of electronic health records. It
is a strategic problem if we don’t have good answers in privacy and security.
It can block the whole thing.

Senator Frist on Wednesday when he spoke to the plenary said privacy and
security must be drilled into the system. He gets it. Congresswoman Heather
Wilson, a Republican from New Mexico, yesterday when she was questioning
Secretary Thompson in a hearing came right back to the privacy issue as the
first and hardest problem that she hears from her constituents. So unless there
is a good, credible technical and publicly acceptable story on privacy and
security, we can see obstacles to the development of the other good things that
can happen here.

My third point has to do with the national identifier. John just told you
some of the technical sorts of obstacles towards using a unique health
identifier — lots of transposition and transcription errors in a single
identifier, it is hard to build a data field. Going beyond that effort, from my
work in other industries, a lot of authentication on the Internet, in other
places, is now being done not on the basis of unique identifiers, it is being
done through multiple other systems that use multiple points of information
that use multiple tokens plus information plus passwords. There is a lot of
things that are done besides unique identifier, and that is how distributive
systems have worked in other industries. It is likely to be how they are going
to work in the health care system if we really want to build them.

So that is a technical point, the public acceptance point on national
health identifiers. I think as shown from our HIPAA experience, Congress
already passed a law requiring a national health identifier. They did it in
1996. Eight years later, it is nowhere in sight, and there is no real prospect
it is going to happen. So if we have to wait for that from the political
system, we are going to be waiting for a long time. We ought to make other
provisions.

My fourth point has to do with this network of networks, or federated idea,
for how the records will be held. Again, when you look at the Internet, you see
that the move towards federated instead of centralized systems has been the way
important systems have gone.

For instance, Microsoft had its so-called passport system that was rolled
out in a more centralized way. There was a very negative and very powerful
reaction against that from a lot of different stakeholders. They shifted to a
federated model for how they do sharing of records for e-commerce. The Liberty
Alliance and other authentication and interconnection systems have moved to
this federated approach. There are reasons why that has happened elsewhere that
are likely to happen in the health care system. Again, that is a technical sort
of thing.

From the public acceptance side, if you imagine the one big centralized
database, you can imagine that is a single point of failure, that is a point of
concern for the political system and the rest. It is not likely to be very
sustainable. There is likely to be problems there that would lead to public
pushback.

The points I have just made are all included in the Connecting for Health
report about the importance of building in privacy and security, the importance
of not waiting for a national identifier, the importance of holding records at
the edges and learning how to link them.

I am now going to take the chance of being up hereto talk for 30 seconds
about a different topic that is not a Connecting for Health topic. It has to do
with something this committee has worked a lot on, which is biosurveillance and
de-identified data and things of that sort.

I would just point out, related to these privacy and security concerns,
there is increasing issues about how biosurveillance in public health will get
linked with law enforcement surveillance for a variety of reasons. I have a law
review article in the Minnesota Law Review from two years ago that has several
pages of discussion of this. I suggest that if the biosurveillance system
depends for its funding and support on linking to homeland security and linking
to law enforcement, there is a long term risk that the public will not be
feeling as free to talk to their doctors.

Just imagine, for instance, if we have a communicable disease such as SARS,
and if people in the immigrant community start to think that going to the
hospital is equivalent to reporting to what used to be the INS. It might just
be that people who are immigrants won’t decide to tell their doctors, or won’t
decide to go to the hospital. We will be able to have pockets of continued
infection that won’t be cured.

So if we mix biosurveillance and public health too closely with law
enforcement surveillance, I think there is a significant risk. But I do want to
emphasize that wasn’t a Connecting for Health moment.

DR. MILLER: Hi. I am Robert Miller. I am a health economist and faculty
member at the University of California-San Francisco.

Our working group addressed two sets of issues, the financial and support
mechanisms needed for widespread adoption of EHRs in mostly small and medium
sized physician practices. Widespread interoperability is impossible without
such EHR adoption. Second, we looked at the organizational and legal issues
that have to be addressed to achieve interoperability.

I am going to address the financial and support issues, but not the other
issues. They are addressed in the materials submitted to this committee.

Since physicians in ambulatory care practices are on the front lines of
treating patients, obviously if they use IT for quality improvement, that has
the potential to do a lot of good things for patients. However, if physicians
have a low adoption rate of electronic health records, it is probably in the
neighborhood of six to 13 percent.

As a working group, we focused the majority of our analysis on small to
medium sized physician practices, since these practices account for the large
majority of physicians in the United States. They also face more challenges in
IT implementation and effective use than do larger health care organizations.

So in our analysis, we modeled the costs and benefits of EHR use for a
typical outpatient physician practice of five physicians, looking at a
three-year period. Our recommendations as a working group are as follows.
First, as a general point, financial incentives must be realigned. For many
physicians, there is simply not a good business case for electronic health
records. The financial and time costs are too high, and the financial benefits
are too low. This is especially true in small and medium-sized practices.
Physicians as a group won’t adopt and use IT for quality improvement unless
they are rewarded for doing so and not penalized, financially penalized, as is
the case today.

Second, we estimated that financial incentives in the approximate range of
three dollars to six dollars per patient visit or 50 cents to one dollar per
member per month over the three-year period, appear to be a sufficient starting
point to encourage and sustain widespread adoption and use of EHR technologies
in solo small group practices.

These incentives will cover most EHR related costs for most practices, but
not necessarily all costs for all practices. The estimate is a large absolute
number of approximately seven to 14 billion dollars per year for three years,
but a small relative number at 1.2 percent to 2.4 percent of the total amount
spent on ambulatory care in 2003.

Payors are currently experimenting with incentives that encourage IT
adoption, as well as that encourage extensive use of EHRs for quality
improvement. It is the ultimate content and level of these incentives that will
have a powerful effect on the pace of IT adoption and quality improvement.

The third point is that the qualitative analysis of the working group
supports a business case that it is better for some clinical incremental
applications than for others. Some physicians can implement these incremental
applications as steps towards the full implementation of an EHR, but only if
they are not dead-end applications. Otherwise, it is something of a waste.

Fourth, the greater the electronic information exchange amongst IT systems,
the better is the business case for EHRs, and for other IT for physician
purchasers. Really small and medium-sized practices have the most to gain from
electronic information exchange.

Finally, small and medium-sized groups require greater attention of support
services to help them to effectively use IT and thus produce quality benefits.
Demonstrations in other efforts will be necessary to determine the best
mechanisms for providing these support services.

Thank you.

DR. LANSKY: Good afternoon. I am David Lansky from the Foundation for
Accountability. I have been serving as the chair of the PHR-EHR work group,
which has this long title, I can’t even read it to you.

I want to talk briefly about two things we did in behalf of the personal
health space. First of all, I want to thank you for having introduced the
country to the emphasis on that in the report you did a couple of years ago.

Two things I want to mention. One is, what is the public appetite for this,
and how do we support greater public interest in the NHII broadly. Secondly,
where do we see the next steps being in the personal health record environment.

The road map document that you have seen makes these recommendations, one
of which is around common communications strategy, repeating what Peter and
others have said about privacy and security. The third one recommends a core
set, a common framework of tools that should be recommended to those, both in
the EHR and PHR world, so that they can talk to each other. Finally, we think
it is time for some demonstration projects.

I want to give you a quick flavor of the messaging piece in particular,
because that tends to be new for many people.

Among the things we found in the research we did with the general public is
that most people have just never thought about this before. For a large part of
the public, we don’t have prior beliefs or assumptions that are problems, but
neither do we have a level of understanding or acceptance that facilitates the
adoption. Most people do want the benefits that the electronic health record
and the personal health record could make available. Some groups as we have
just heard on the incremental applications front, the same is true in the PHR,
some groups are more likely to adopt specific incremental applications than
others. We have tested some advertising strategies to see if we can create more
public interest in this, and that seems to work well. We are beginning to
encourage people to think about a common campaign.

Just to give you a quick flavor of some of the things we found, a
surprising number of people as you see here believe their doctor already keeps
their medical record on a computer. So the idea of saying to the public, here
is a problem, you need to help us fix it is actually a new piece of information
for many people.

When we asked people, would you like the benefit of the services that this
connected network could provide to you, we get very high rates of agreement
with these common services, e-mailing, looking for mistakes in my record,
looking at lab results and so on.

In testing some messages, I also wanted you to see here, there are quite
different segments in the population, by the percentage of agreement with these
different messages. But also, that from the messages you see with low scores,
those bottom two — I am tired of playing telephone tag, and I feel that the
health e has all the power — certain ways of communicating about this work
don’t appeal to very many people. It is very important that all of us think
together on behalf of the public officials and our own organizations that we
find some language and some words which create a constructive opportunity
oriented message to the public that engages interest and deals with the prior
levels of knowledge.

Just for an example, we did test this advertisement and got a very positive
response. Here the person is falling off the ladder, and the tagline says, you
have three seconds to remember every doctor you have ever seen and every
procedure you have ever undergone, every medicine you have ever taken. Very
high percentages of the population find that to be a persuasive message. That
is an example of how we might want to proceed in communicating with the public.

As I mentioned, the road map does suggest some common technical approaches
to PHR and EHR development, so that they can talk to each other. That has been
the subject of the meeting here this week. We do encourage demonstration
projects in PHR, where we had some criteria we recommended. As you heard this
morning from the work group here, there is a lot of convergence in those
working in these fields of the kinds of demonstrations that should happen next.

Thank you.

DR. DIAMOND: Thank you. I just want to thank the committee for the fabulous
work you have done, and the Chair for indulging us a little bit of extra time.
Thanks.

DR. LUMPKIN: Thank you. We have time for a few questions. Simon.

DR. COHN: First of all, I want to thank our presenters. Carol, I read the
whole document over, and I think it is a terrific document. So I really want to
thank you for advancing the science and putting some new thinking in the area.

There was one area I need some help with. Maybe it is a question for John
and Mark. I am reflecting a disconnect between the presentations this morning
and what I am hearing from you this afternoon.

Mark, this morning you presented a specific recommendation to the NCVHS as
part of your standards and architecture activity related to patient identifier.
It reads, the NCVHS should recommend within six months whether a national
patient identifier should be used for the NHII.

Now, I think John, I presume you were part of that work group also, are
convincingly trying to recommend that such a thing is not necessary. I am
feeing a little bit of a disconnect. Can you and John potentially tell us
whether this is still an open argument, or why are we seeing such a disconnect
here?

MR. OVERHAGE: Thank you. The recommendation that was presented this morning
was the work of the work groups yesterday, and attempting to synthesize a
variety of opinions. I do not think — and John, you can disagree with me if
you wish — that there is broad consensus that the answer is that we don’t need
to advance too quickly on the national identifier.

The recommendation in the Connecting for Health group — and it was a
wonderful, fascinating journey, because we had non-health care and health care
people, and a whole variety of folks who work in this area on a daily basis —
was really a revelation for us, to say, wait a minute, even if we have a
national identifier, let’s do a thought experiment, we still wouldn’t rely on
it as the only linking mechanism, and there is good evidence.

So our conclusion was in this group that we don’t need one. It is not
critical. We hope that the committee will weigh that information in thinking
about responding to the morning’s recommendation.

DR. SWIRE: I had a two-hour discussion on this for two hours last night,
and what came out of that is, this architecture I have described has selected
demographic elements — name, date of birth, mother’s maiden name, zip code.
That links to institutional specific identifiers as a map of where your records
live. It does not preclude the future use of a national health identifier. It
just becomes another data element that is going to make the matching even
better, a name, date of birth, mother’s maiden name kind of match. But to say
we can’t get started until we have that data element is really a non-starter.

So this is a nice synthesis, fine. We build a distributed directory system
with demographics, and sometime in the future, if we really need one, there is
a compelling argument — or the political tide changes, we could add one. Let’s
not do it now.

DR. YASNOFF: If I may, I just want to add to your question, Simon, that
this is an issue that has been debated rather extensively over many years.
Clearly, I now interpret — when people say we need a unique identifier, what I
hear them saying is, we need a reliable process to identify patients. That is
what really is being said when you question people. Typically, that is really
what they are saying. They have the belief that a national unique identifier
would serve in that capacity.

But as was said, when you analyze the problem and think about how it will
work, and take into account the political realities and so on, it turns out
that that is not a solution to what admittedly is a very critical problem.

I also have another question.

DR. STEINDEL: Just adding a reinforcing comment to what Bill just said. In
the group that I was in, which was one of the confidentiality groups, the issue
came up of the national patient identifier. They wanted it, because they wanted
to be able to match records reliably, just the issue that was brought up here.
After speaking to the group with the problems of matching records using a
national patient identifier and still needing other information, there was the
realization of the group that they were actually asking the exact same question
that Bill is hearing in his mind when that question is asked. They are not
asking for a national patient identifier, they are asking for a unified system
that can reliably identify patient information.

DR. YASNOFF: I have a hopefully brief but somewhat detailed question about
the estimates of the approximate range of financial incentives needed. Can you
say something about how you developed that estimate?

DR. MILLER: First of all, these are preliminary estimates and we used
available data. We developed a couple of use cases where we just marched
through what the cost might be for a practice of implementing various elements
of the EHR, and broke them down into a variety of components — hardware,
software, lost productivity and physician time, support costs and on and on. We
did that at a fairly micro level.

Then what we did was compare that to some more larger scale estimates as
to, if you just take a look at what it costs a practice to do this, what would
a ball park range be. Miracles of miracles, they tended to coincide, the
detailed estimates and the overview estimates.

There is more information that is needed. I think in particular for the
benefits side, it is easier to get at the costs, although it is certainly not
easy, harder for the benefits.

DR. YASNOFF: So is there an assumption behind these numbers — is what you
are trying to do with these numbers essentially to pay physicians for what
amounts to the complete cost of the system?

DR. MILLER: That’s right. For the cost of the system and taking into
account the likely anticipated benefits, these would be the net costs to the
physician over the three year period. DR. YASNOFF: So the question you are
essentially answering, and this is the last point, is, you are essentially
saying if we through some process pay physicians the full cost of installing
these systems, then our expectation is that that will incentivize adoption. But
in doing that, I assume you would not exclude the possibility that if there is
an amount less than that you could pay, it would still strongly incentivize
adoption.

DR. MILLER: I think Carol is right, nobody knows what that number is. A
last point I would make is that there are various ways to create these
incentives, but I think there is an underlying assumption that at the end of it
all, there will be incentives for quality of care improvement to encourage
ongoing use by clinicians of the EHR for quality. There has to be a conducive
overall reimbursement environment.

DR. YASNOFF: Thank you.

DR. DIAMOND: I just wanted to add something to the answer for the
incentives, because it has been the topic of a lot of discussion. As Bob said,
nobody really knows what the right level is, but in addition to the analysis
that the work group did, we looked at some of the early experimentation with
this, and I think John Brosser, who is the chair of the group, was looking for
what do peoples’ experience indicate is enough to cause tilt. That ten to 20
percent number has come across in Bridges to Excellence and other programs that
were things that we looked at. But there is no data. There won’t be any new or
great data any time in the very near-term future. So it is an attempt to try to
take whatever evidence is out there.

DR. YASNOFF: The only data point that I am aware of is the experiment that
was done in Maine, where they offered $5,000 per physician one-time incentives,
which by any measure is not close to the full cost of EHRs. They got
practically universal adoption.

Now, of course, other people will argue that Maine is unusual, and I am not
going to get into that, but that is the only data that I am aware of, of
specific incentives for IT in physicians’ offices. If other people are aware of
data, I would be interested. I don’t know if the committee wants to take the
time on this.

DR. COHN: I want to move on to our next question from Gene, but there was
actually testimony on e-prescribing, that I think it was between $15,000 and
$20,000 to be given to physicians, and they seem to be doing a very good job of
incenting use of e-prescribing systems. That is recent testimony to one of our
subcommittees.

DR. STEUERLE: Let me also compliment the work you did. I think it really
advances the bar. as well as complimenting Markle Foundation and RWJ. I think
Robert Wood Johnson, one of their principal contributions to our effort is
their giving us John Lumpkin’s time. I think he has turned this into his day
job.

Speaking of time, that gets me into my question. This is only anecdotal,
but when I have talked to a number of doctors about why they may not have
adopted electronic health records and stuff like that, the biggest issue they
raised with me is not that they are facing $5,000 or $10,000 or $20,000 of
costs. Maybe it is because I live in Washington, D.C. and they are all higher
priced doctors or something. It is that they are worried about the time. It is
not even the time of the nurse or somebody inputting data, it is themselves.
They say, I don’t have time to transcribe everything I write over into a
record.

You and I might say they learn to type, or maybe there are quick ways we
can put this in, but I am just curious whether anybody has investigated the
time involved in this, and whether that is a major obstacle to incentivizing
doctors to move in this direction.

DR. MILLER: The work group took seriously the issue of time. In fact, in
the estimates there is an estimate of the cost of that time, which is in the
work called productivity losses; it is hidden under that label. But there are
numerous time costs to clinicians, more so in small groups that they have less
support, just getting up on the learning curve and making associated changes in
the practice that are needed.

What we attempted to do was to build into the cost estimates, that. But as
I said, one of the points that I made was that the range of estimates will
cover most costs for most physicians, but not all costs for all physicians. In
part, some clinicians are going to have severe time costs. In that case, we
don’t know how much it is going to cost for them.

MR. OVERHAGE: One point. There is a bit of evidence out there. Most of the
evidence suggests that it does take more time. There is some evidence that a
well-tuned system well implemented in a randomized control trial took no longer
for people to use. That is a big leap, to say well tuned, well integrated, but
it does give us some hope that we can get there.

It also emphasizes — your question is a very important one — it
emphasizes how critical the work flow implementation aspect of all of this is.
When people talk about incentives and so on, buying the system is a tenth of
the problem or a tenth of the cost.

DR. STEUERLE: Can I follow on with a related question? If we are moving
into this world, has anyone looked at — the time cost has to do with how
trained the doctor is to begin with in living in this type of world. Has
anybody looked at what we should be doing with respect to the medical schools?
I know it is a question for our committee and a question for your group. Did
this at all come up in the discussion?

DR. SWIRE: I am also responsible for all the educational technologies at
Harvard Medical School. Starting this year I will lead a course in the use of
information technology, talking about how the medical record systems of our
institutions work. It is just one day, all medical students oriented to, how do
I actually get to this new electronic world.

DR. STEUERLE: Required course?

DR. SWIRE: It is required for everybody.

DR. STEUERLE: You have given an anecdote, but generally speaking, has
anyone addressed the issue more broadly?

DR. SWIRE: No, have not heard of it.

DR. VIGILANTE: Actually, Bill asked my question for me, the methods used to
estimate the necessary reimbursement for a doc. Is that methodology published
anywhere? Can we access some more detailed information on that?

DR. DIAMOND: One thing I should have explained at the beginning is that the
work that comprised the road map and brought it together is done in a series of
working groups. Bob’s working group, which is now chaired by John Glasser, we
will be publishing their report at the end of the summer, and that will include
the methodology and all the underlying analysis that they did. But in the
preliminary road map and preliminary recommendations for all the areas, they
represent the bubble-up, high-level recommendations.

DR. VIGILANTE: As inadequate as this is, has any thought been given to
doing surveys and focus groups to physicians about whether this would incent
them, those who may be slow adopters or in a contemplative state, to move off
the dime?

DR. DIAMOND: I think some focus groups have. I know some did some when they
were first putting their program together, but I would support the fact that we
need more. I think we need to understand this. This will be a level of
experimentation for awhile, I would guess.

MR. BLAIR: My compliments to Connecting for Health. I think it is an
outstanding report, and I agree with almost every single recommendation. There
is one that I might like a little bit of clarification on, which is referring
to standards that are dead end.

The thing that I began to think of when it indicated that there are
standards that are dead end, was when I took a look at the terminology field,
where the NCVHS identified a core set of clinically specific terminologies,
including SNOMED and LOINC and Rx Norm. From our perspective, we didn’t use the
phrase dead end for terminologies that were not that core, because we
recognized that even though some may have been either developed earlier or
later, they performed some business function that the core hadn’t yet been able
to perform or can’t perform quickly or can’t be developed quickly, whether it
is MedSyn or ICD-9 or whatever. So we wound up indicating that there should be
mappings and linkings to those until things changed and consolidated.

This is said with the expectation that your primary goals we very much
agree with, and that we should have interoperability and we should have
convergence. We don’t really want to have standards that are, quote, dead end,
but I am just trying to make sure that the phrase dead end doesn’t also include
standards or terminologies that do perform or meet a business need, just need
to be mapped or linked.

DR. BISHEL: Jeff, we agree very much with your statement. Just to clarify
the statement we made for Connecting for Health, we were talking about
applications that were dead end, as opposed to standards that were dead end, in
the sense of these EHR applications. There is a debate about whether in
installing that, you are cutting off greater progress or not, and we were
trying to use standards as a way to have your cake and eat it, too, in that
regard.

Having made that clarification, everything you said we completely agree
with.

MR. BLAIR: Thank you.

DR. DEERING: I’m sorry David Lansky left, because this would have been
addressed to him. But Carol, I guess you will probably have to take it.

I wanted to say as others have that in particular, the work that you have
done to pick up the personal health dimension and move it forward — and in a
way, you have given an example of your own communication principle, and I don’t
think anyone else has taken the language of personal empowerment and personal
health records and translated it into language that policy makers and people
who work in the weeds of standards and legal issues can understand. So I really
congratulate you on that.

You also picked up the notion of patient control of their health
information early, and you elevated it. I sort of suspect that it was your
vetting of that concept that helped bring it into other policy circles. That is
an enormous issue, given that neither laws nor regulations nor practice
supports it.

Within your discussions, did you talk about the enormity of that challenge?
Did you characterize it vis-a-vis standards efforts? And do you have any ideas
about how to carefully go about it?

DR. DIAMOND: It is an excellent question, and we did. Peter and John may
want to say more about this. I think the model we put forth in terms of patient
control was very specifically focused about information sharing and information
exchange. We felt it was important that it be built on a premise of patient
authorization and patient decision making with their physician or whoever else
was participating in the network about what can be shared and when it can be
shared and how it should be shared.

I do think that we have not grappled with the enormity of patient control
over their information enough. One of the things that we hope to do in the next
phase of Connecting for Health as we think about demonstration project and the
reference implementation is to explore that further. I think anything short of
giving patients the opportunity to decide whether or not they want health
information to be shared will not succeed, and I think we need to build a
system with that premise in mind.

DR. SWIRE: Just a comment about the demonstration project. The NLM funded
Zach O’Hunney and Ken Mandel to do the NMESH data exchange and PING. Israel
Deaconess Medical Center has long run Patient Sight, a patient personal health
record with access to all the laboratories and results and various meds and
allergies. We are now building a bridge which enables the patient to download
all the hospital data into a CDA compliant format, and then carry it over to
the Children’s Hospital PING and MESH record systems. So we will very shortly
have an early experience to share with you.

Agenda Item: Discussion of Strategies

DR. LUMPKIN: Thank you very much. We appreciate all the work that you have
done. I just want to say, as much as Carol tries to deny it, those of us who
have worked on Connecting for Health know that we wouldn’t be here without her.

Our next task is to synthesize what we heard today, and to set an agenda
for us as a work group, what are the issues that we want to have hearings on.
This discussion is going to be somewhat of a change from what we have talked
about as potentials for what we have worked on in the past. I am just going to
set the stage and then move us into that.

The goal is that when we are done, we will have some concept of what we
want to — where we believe we as a work group can have impact on helping the
Department address issues to further roll out of the NHII, where we may shine a
light on areas that may need additional expansion.

In the past, we had talked about as our agenda setting the development of a
long range road map. We have also talked about looking at identifying
additional dimensions to the National Health Information Infrastructure, and we
have talked about other areas that we may want to look into as we that long
range vision.

I think that as we discussed in our meeting in January, one of the
challenges that faced us is that every time we tried to pick up a subject,
someone starts running with it. By the time we get to thinking about writing a
report, it becomes superfluous. Thus, the concept of a road map may not
actually be a unique idea. But I think that there are other areas that we can
have some significant impact.

One of the dimensions that we had talked about was the concept of research
as a dimension. We played around with some others, but we were fairly
comfortable with that. Clearly there were recommendations today from the
research group that were other areas that we might explore. Looking through the
various documents that are also recommendations related to the personal health
record, obviously there were a lot of recommendations on privacy. However, we
have a full subcommittee that deals with that, and I think they can take a look
at that. But those are some of the things that I picked out.

What I would like to do is suggest that maybe the first half an hour or so
we will throw out some ideas, and then we will try to comb down the list,
identify what we want to do as part of our ongoing efforts, and then in our
September meeting actually pose these to the executive subcommittee in its
meeting later this month, early next month, and finalize it at our meeting in
September, if that is agreeable.

MS. POKER: Before we proceed with the research, just a thought. Today I
counted four road maps that are out there. There is the IOM report on patient
safety, NIH road map, there is Dr. Brailer’s road map, there is the
connectivity road map. Is there a need for this committee to do a synthesis, a
crosswalk, some sort of a document? Where do these road maps connect? Is there
something that is missing? Are we going to adopt one? Are we going to
synthesize them all? Which one is going to be the road map? Who is going to
decide this?

In other words, I think maybe the road map is not exactly over. Or is it
over? I’m not clear on it.

DR. LUMPKIN: Point of discussion. Anybody else want to raise the issue,
discuss the issue of whether or not we feel there is some validity for doing a
road map or doing a synthesis of the road maps that are out there?

DR. STEINDEL: I think when we look at some of the road maps that were
mentioned, we had a comment from Dr. Zerhouni with the NIH road map that it is
meshing with the road map that was talked about and presented to us. I think
when we are looking at the federal efforts on road maps, they may not mesh
today, but there is going to be an effort within the Department to mesh those
road maps under a common framework.

I don’t think it is productive for us to look at that framework. I think we
have gotten the sense that it is moving very quickly, and given our meeting
schedules will probably be overtaken by events. So I really don’t think that is
that productive, to go forward with studying what paths people are taking. I
think it is very productive to look at some of the way stations on the road,
like you pointed out, some specific topic areas and stuff, maybe look at those.
Hopefully they will be in place by the time the construction equipment meets
that point.

DR. LUMPKIN: Other thoughts, either on the road map or areas that we may
want to take a look at?

DR. YASNOFF: I think your point about what the work group can contribute
within the time frame in which we can produce things is a very, very important
one. Also, I think that the strength of the work group is the ability to bring
in the views of all the stakeholders in a systematic way and try to synthesize
those and provide those to the Department.

So I just listed four issues that seem to be very, very important ones, and
I’m sure other people can list others. There is the issue of incentives, there
is the issue of interoperability, there is the issue of legal obstacles that
keeps coming up over and over, and there is this issue of certification of
EHRs.

Now, I am going to at least in my own mind cross off the issue of
incentives, in the sense that there seems to be a consensus already that
incentives are needed. People are looking at what they are. The Secretary
announced this group that is going to be formed to look at them and so on. So I
think that is an issue that I don’t see how the work group could possibly
really help there.

But I think in the other areas — and I’m not sure which one or ones would
be the best ones, but in the area of defining what interoperability is going to
mean on a practical level, how it needs to be enforced, there was this
recommendation we heard earlier today for an organization to deal with
interoperability, is that really what needs to be done. That is what the people
who came to this meeting thought, but what do other stakeholders think?

Similarly with the legal obstacles, should we be thinking about those legal
obstacles? Is that an area we should ignore? Then with respect to this idea of
certifying electronic health records, how should that be done? Again, there has
been a recommendation in the strategic framework that there be an organization
to do this. How should that organization be formed, governed, what should it
do? Should there be minimum standards, maximum standards.

I think those are areas where there is tremendous potential for the work
group to contribute by assuring comprehensive and effective and timely input
from all the stakeholders.

DR. CARR: Maybe I am thinking more in terms of the whole committee as
opposed to the subcommittee, but we had hearings last month on quality, and
following up on the eight candidate recommendations about including quality
elements on the UB form.

I just wonder if, given the accelerated tempo of your electronic health
record, if there shouldn’t be a redirection of those candidate recommendations,
in terms of identifying how information about quality is collected, and should
we be looking at the UB form, or should we be looking more at the electronic
health record and help coordinate the various initiatives we heard from last
month.

DR. LUMPKIN: Let me see if I understand. I think that is something that the
quality work group of the Population Subcommittee is taking care of. I don’t
know if you are suggesting that that be something that we place on our agenda,
or —

DR. CARR: I think stepping back to the whole committee, the quality work
group has been focusing on finding a way to get quality data elements through
the UB code. I think at our last large committee meeting, you had brought up
the issue about quality transaction, whether that would be something more
flexible, going forward, given all the demands.

So I realize that it is the work of the quality work group, but it is the
crosswalk within NHII, where within the electronic health record would there be
a quality transaction or somewhere for that to happen.

DR. LUMPKIN: Simon? On this point?

DR. COHN: I was going to maybe jump in and clarify a little bit, only
because I had the opportunity to sit in on the quality work group at the last
meeting. I think it was sort of an ah-ha, that this issue that you need to bake
quality in — it is not quality of care, it is quality measures, it is quality
metrics and all of this stuff, into how you put all this stuff together, the
same way that you need to bake security and privacy into EHR and NHII from the
beginning, rather than as you put something on top of it.

Now, I guess I see this almost as a broader issue, which once again I put
on the table for this work group. There is this view, like all of the secondary
users of information relating to the NHII, and maybe some of them are primary,
but it is population, it is research, it is public health. It is quality, it is
all of those people who want to get their hands on the data or want to add data
elements to it, or want to do whatever.

Whereas, it is pretty clear to me how providers and even patients can
interact, and there is a concreteness to how that happens in the world of NHII.
The rest of this is a little vague. It is a little uncertain to me how this
plays out. We may want to take a look at it from those various dimensions.

I just bring it up, because I think it does include quality, but it also
includes research and all these secondary uses.

DR. CARR: That is a good way to look at it, primary and then the secondary
uses. We sure heard a lot of people who have a lot of ideas about what the
potential is, but they were diverse.

DR. LUMPKIN: Would it be a fair summary that that topic would be secondary
uses of clinical data?

DR. COHN: Or the NHII.

DR. LUMPKIN: EHR maybe, but not the NHII.

DR. COHN: Okay, yes, you’re right.

DR. LUMPKIN: So secondary uses of data from the EHR. Eduardo.

DR. ORTIZ: I wanted to revisit the issue of the incentives, as Bill was
talking about. Obviously as we heard today from this Connecting for Health
report, we still know so little about what it takes in terms of incentives, and
we don’t have very much data. Even when we have data like this, it is still
very unclear what types of incentives are needed, what types of barriers are
there.

So for example, if you paid clinicians to put these systems in, first of
all, you have got to get good data on what it would cost. But if you paid them
to put this in, would that be really enough? Do you need to pay the entire
amount, do you need to pay a certain amount, like in Maine, where they were
able to get $5,000? If you gave these clinicians the money to put this in,
perhaps that still wouldn’t do it for a lot of clinicians, because maybe they
are not aware that there is a problem. So why do I need to put this in, disrupt
my system, et cetera, because there is nothing wrong with the way I practice
medicine. I don’t make mistakes, et cetera. That is maybe a huge group out
there.

There is just a lot of other issues out there in terms of incentives. If
you put this in and paid them to put in these systems, but then you didn’t link
that to paying them for quality, having differential reimbursement for quality,
would that be enough?

I think there are so many iterations of how you can provide these
incentives, that we just don’t know. Unless we can really get a good handle on
what incentives are needed and what the barriers are, and how to overcome them,
it is hard to go very far. If you can’t get clinicians, especially solo
practitioners, group practitioners, people out there in the community, to
really adopt these systems, it is really hard to move forward.

So I agree that there is a lot of stuff being done out there already.
Connecting for Health is working on it, the Secretary is working on it, but I
still don’t know if that means that we shouldn’t tackle that. I still think
that there still may be an important role for us, either one, because maybe the
stuff that is being done out there isn’t enough, or perhaps we have always
served a role as a convening facilitating group, where we can bring all these
efforts in at this table in a very objective way.

So I think that is something that we should still keep on the table. Unless
you really feel that there is enough out there that other people are doing it
where it would be redundant, I would still like to keep it on the table for
possible hearings.

DR. LUMPKIN: Steve.

DR. STEINDEL: John, I have two comments and suggestions. One is picking up
on what Bill said. He listed three items, interoperability, legal aspects and
certification. What I was struck by was, I can group these under a rubric of
categories that we really haven’t defined. What are the rules of the road for
the NHII? What is needed to participate in the NHII? What type of legal
constructs allow you to get on the — using Clem’s analogy of the highway? What
type of legal constructs are needed to get on the highway, what type of
certifications, approvals, if we want to use a word other than certification,
do you need to get on the highway? Can you fit on the highway, using the
railway analogy about track sizes?

So maybe we can group all of those under a common subject of what are the
rules of the road to get onto the NHII, and hold hearings and explore multiple
areas that we could be suggesting to the Secretary, as, if you want to
participate on the NHII, your group, whatever we are going to call it, whether
it is the EHR vendor, whether it is a regional health information organization,
what attributes they have to have to participate? That might be something that
is interesting to explore.

A second suggestion goes along with the secondary use of data. Another
thing that we forget that this work group periphery produced was the vision for
21st century. That is a lot about secondary use of data. How does the vision
document fit in with the growing road map of the NHII? What is needed to make
that vision fit into what we are seeing today?

So those are two suggestions.

DR. LUMPKIN: Kevin.

DR. VIGILANTE: I want to second what Eduardo said. I like the three things
that Bill talked about and the way you framed it. But I do think incentives are
so fundamental that I am not ready, I think, to abdicate it completely to the
higher powers that be.

So I have no doubt that they will dive in deep and do a great job, but I
just see it as — if you could get a 25 to 30 percent adoption rate a year
among docs, a lot of these other issues would be solved by the marketplace.
That is my bias.

So I think the issue of incentives is so fundamental that I think we should
— I’m not ready to walk away from it yet, personally. I would really like to
hear from OMB and CBO what they think the ROI is, what do they think the
investment is worth, or not, and why, their thinking about this, because I
think we have to understand that.

DR. LUMPKIN: Marjorie.

DR. GREENBERG: I just wanted to pick up on Steve’s comment about the 21st
century vision, and then we were talking about secondary uses.

I do think one role of the committee and of this work group is to keep the
overall NHII vision alive. I think for understandable reasons, a lot of people
are equating NHII with EHR, but the vision was bigger than that, so it is not
all only about the EHR and secondary uses of the EHR; it is also obviously
about the personal health record and secondary uses of that. But also, it is
about other information in the community or population dimension. Some of that
could possibly, as were some of the recommendations, transition to actually
using information from the EHR, but some of that information needed in
population health and all the information on influences on health will never be
in the EHR. Some of it may be in the PHR, but of course, there are huge issues
there about access.

So I think the EHR goes beyond secondary uses of the EHR. I think this
conference was about health care, but the NHII is bigger than health care. So I
would just — and I think everyone in population health and public health was
very pleased that the four goals included a goal for population health. So I
want to recognize that. But I still think this is the committee that will keep
that overall vision and the interconnections between the different dimensions
alive. It may be an argument for looking at adding a research dimension, I
don’t know. But certainly as a population health person, I would encourage
that.

DR. LUMPKIN: Judy.

DR. WARREN: I just wanted to caution us a little bit about incentives. When
we think about incentives, it is usually money. One of the physicians that was
in a group with me yesterday said six dollars per patient per visit would not
be enough to incentivize him to use the record. Partly, that was because the
record itself in the applications he was familiar with took up far too much
time.

He saw routinely 30 to 50 patients a day, and he would be in his office
until he saw the last one. If the design of the system, et cetera, over the
requirements of that system took up all that time and kept him in his office
until midnight, he wasn’t going to use it. So I think when we think of
incentives, we need to think of much more than just money. It needs to be
packaged.

With that, I liked what Steve said about taking a look at rules for the
road, that maybe we need to reframe incentives within that paradigm to help us
look outside incentives as being only money.

DR. LUMPKIN: Bill.

DR. YASNOFF: I certainly agree with what has been said about incentives,
they are absolutely critical. I didn’t mean to imply that they were not, or
that we should not pay attention to them.

My issue is that I think for what we are able to do as a work group
primarily is to synthesize opinion and get a wide range of views. I think that
with respect to incentives, I think the way we are going to progress is not
with synthesizing views of experts, but it is going to be through research,
survey research and actual experiments with incentives to determine what types
of incentives work, paid in what way, and inducing what behavior.

I am afraid that we could take testimony for days and days and days, and I
don’t think we would know any more than we know now or that we would be able to
do anything productive with that.

So it is not that it is not critical. It is just that the mechanism we have
and our ability to do things I don’t think fits that problem.

Similarly with respect to the secondary uses of data, I again agree that
secondary uses of data are critical. I think over time, much of the value,
maybe even most of the value of building the NHII is going to come from
secondary uses of data.

But what I would argue is that where we can contribute in an issue that is
very urgent are in these — and I like Steve’s characterization of rules of the
road, because these issues — and let me pick on this certification issue,
because I think there is a developing consensus that some kind of certification
is needed. These are issues where the obstacle to progress is getting agreement
as to what should be done. That is an area where this work group has a lot of
experience. We have the mechanisms, we can reach out to the stakeholders, and
synthesize opinion, which will be very helpful to the Department and to the
Congress in terms of, if action needs to be taken in this regard.

So that is why I think we — and those issues are very, very urgent on the
next steps in this process. So the issues of certification and then the issues
of interoperability and these legal obstacles, perhaps other rules of the road
— the rules of the road are things we agree on, and so that is where I think
the mechanism of our work group can really contribute a lot. Whereas, our
ability to do research is limited, and ultimately we would just be competing
with or using the same mechanisms that everyone else uses.

DR. LUMPKIN: Mary Jo.

DR. DEERING: Echoing my comment to Carol, there are equally huge issues,
many of which we may not even know, regarding the federal government and
personal health records. We have CMS saying that it is going to start a
personal health record, although to start with, it will just be letting people
view their beneficiary, their Medicare claims information, et cetera. But they
seem to be moving in the direction of Newt Gingrich’s suggestion.

We have the OPM talking about the FEHBPs, and trying to see what it can do
to incent them to use electronic health records. I know that the National
Cancer Institute is very interested in looking in this direction.

Clearly, the issue of patient control is over one aspect of it. Are there
other special issues that we don’t even know about that we might need to
explore. If everyone’s rhetoric supports this concept of person-centered,
patient-centric, consumer driven health care, what are the actual policy
barriers and related issues that might need to be addressed to move us in that
direction?

DR. LUMPKIN: Stan.

DR. HUFF: A couple of thoughts, and it may be that both of these should be
in Standards and Security rather than in NHII. But I would just like to pursue
further the idea of patient identification. I think I am persuaded by the
information and the arguments that were presented. I think though that actually
leads then to some new obligations.

That is, I think everybody would agree that accurate patient identification
is essential to a lot of the functions, capabilities, rewards, that we want to
achieve. I think to do that then, we need to either generate or inspire
somebody else to generate standards about how this is done. That is, what
elements do we think are required or should be required to uniquely identify a
person.

The little bit I know from my own background, there are all kinds of things
that need to be firmed up, so we have a common understanding of policies and
procedures, how do we treat hyphenated last names, how do we treat multiple
last names, where do those things go in database fields? It was mentioned today
in the testimony, what is our policy around adoptions, name changes related to
marriages or other things, other sorts of things that maybe we could at least
comment on, in terms of what would be the value of having ID cards, so that
people — that is what is common with us — so that it is faster and easier to
access health care by use of cards. Is it time that we should make a statement
on biometric identification?

So I think to me, again, I am persuaded by the things that were said. I
think that then says what should we do and what should be the policies and
procedures that would lead to good quality patient identification. That might
be a subject for us to do.

The second one comes out of the work groups yesterday. The number-one topic
in our group was this need for an authoritative body that would in fact lead to
— why I say authoritative body, I’ll describe that in a second, but that would
be the source for interoperable standards.

What I mean by that is, we as NCVHS have said we want to use HL-7, we want
to use DICOMM, SNOMED, LOINC, et cetera. But at the level the standards exist
today, that doesn’t lead to interoperability in the way that we are trying to
achieve. We know that there is work that needs to be done to match up the
terminologies to their specific use in the standards. What we have now is, we
have NCVHS, we have KAI, that have different realms of influence. KAI is
internal and binding to some extent on government entities. We have ANSE, HISB,
that is a coordinating body. In some ways, people still are just sitting back
and saying, we are going to wait and see what the marketplace does before we
move to — and people really want more direction than that. They want a set of
people who have the time to get into the details and produce implementation
guides and say, this is the national standard for how you send lab data, or
this is the national standard for how you send prescription data.

I think we are working for an e-prescribing, but I think there are a whole
series of those, and I think it takes real staff, real paid staff, and is there
something we could do in regards to getting those kind of resources available,
so that we have something that is authoritative, that everybody can say, and
companies would feel comfortable assigning resources to implement the standards
as would come from this interoperability committee.

DR. LUMPKIN: John.

DR. HOUSTON: To incentives for just a second, I think that one of the
concerns I have about incentives, or one other way to approach incentives, is
that if things go as everybody hopes, I just wonder at what point this becomes
a standard of care, and there is an expectation that if a physician is going to
be doing his or her job, he or she needs to acquire the information systems and
simply comply, or else.

Obviously in a state like Pennsylvania where I am from, you have huge
malpractice rates and real issues. I think again, it can ultimately establish a
standard of care that people are simply going to have to comply with, and that
is the incentive, that you have to. I’m not sure whether there is anything
above and beyond that, that people are going to be wiling to give back, or give
to these physicians to comply.

DR. LUMPKIN: Eduardo.

DR. ORTIZ: A couple of things. One, I totally support Judy’s perspective
that we have to make sure that incentives is not just talking about financial
incentives. We really have to look at issues about incentives and barriers,
monetary and non-monetary.

Getting back to that, one thing that being with NCVHS for awhile I see is
the way we have done things in the past. I see that this is a perfect role for
us in a way, because of the fact that this is an area that still needs a lot of
work. We don’t have the answers.

What we do as a group that I think is really good is that we bring in
disparate groups, disparate stakeholders. We have hearings, and we are able to
flush things out. Not only do we bring in all these different groups that have
different things, we bring in providers, we bring in consumers, we bring in all
these different groups with different agendas. We listen to them, they present
to us, we ask them tough questions, we really flesh it out. I think this is a
great forum for that.

Instead of the Secretary moving with an agenda and then informing us, I
view it the opposite; we do this and help inform the Secretary, and provide
recommendations that hopefully HHS can then use.

I think it sounds like everybody agrees that the incentives issue is very
important and needs to be fleshed out. It is just whether or not it is
something that belongs in our domain. But I would argue that the way we
function, it is perfect for our domain.

Then I was just going to reinforce that I agree also with Stan’s position
that the issue of the identification I still think is obviously very important,
the issue of how do you put in a process for identifying patients. Although I
think it could be in the Standards and Security Subcommittee as well, I
actually would recommend that it ends up being dealt with in the NHII group,
that it is such an important issue in terms of developing NHII and exchanging
data across clinical sites. I would recommend that we deal with it instead of
Standards and Security, although they are very capable as well.

DR. STEUERLE: I see us as having our own information problem. That is, we
are not dealing in an area that is growing exponentially. The absolute amount
of time that we spend on it is probably roughly constant over time, and
probably the amount of time that the HHS staff, even if they double how many
people they put on it, is still pretty limited relative to this growth.

Part of our issue is how are we dealing with this compounding of
information. Let me just throw out a couple of thoughts about resolving them. I
feel a little bit like the guy who responded to a poster who said, how do I
know what I am thinking until I have heard what I have to say.

One issue is, we talked about road maps, but I wonder if we even know much
about how well we are tracking what is going on. Do we have a good road map of
even what is taking place now? We gather information about what people want,
but do we have a good information system for what is actually going on right
now, not only internal to the Department, but all the private people. I don’t
know. I wonder if that tracking is there.

A second level of issues I see is, the main thing that most of us have
talked about here is, we have all pointed to what we consider as clear-cut gaps
or issues that we need to be resolved in order to move forward. I think we do a
moderately good job there. But again, with this expansion, how do we pick which
of those we deal with?

There, what I’m not sure we have dealt with as well is the who issue as
opposed to just the what issue. We have identified a number of problems, but we
haven’t really resolved the issue of who is in charge of resolving them. Is it
a government function, is it something we leave to the market? Maybe we leave
it to the market because we just don’t know. A lot of times, that may be what
it is. But in a lot of cases, if it is something that should be done internal
to the government, I think we have to start asking who is going to do it.

Then there is this set of things that always lurks in the background. As
opposed to just identifying the problem, at some point you get to the point of
having to identify options. I think most of us have identified that as well as
the committee on confidentiality, but certainly this confidentiality issue is a
major issue that has to be addressed. But at some point, we have to figure out
what options have to be put forward to deal with it, and whether those options
indeed might even be legal or legislative in order.

Again, how do we put those options on the table, who puts them forward? Is
it us, is it HHS, is it the private sector trying to lobby the members of
Congress? I think we have to sort through this growing information issue and
where we want to make our mark. Again, I apologize that I haven’t quite
resolved it all myself.

MR. BLAIR: I have some thoughts in three areas.

DR. LUMPKIN: I’m running out of paper, Jeff. No, go ahead.

MR. BLAIR: The first is in the areas of incentives. Sometimes I feel as if
we are slipping into the mode of looking for incentives for implementing EHR
systems. I think we have slipped off the mark, because the incentives that I
think we really want to put in place are an incentive to improve quality of
care, and incentives to improve patient safety and incentives to reduce costs,
and the EHR systems are the tools that will enable providers to be able to get
the benefits of the incentives we provide for those three areas. I think it is
really important that we keep focused on exactly what it is that we want to
provide incentives for. So that is item one.

Item number two. Obviously I have been in the standards world for a long
time, am thought of as a standards advocate. But there are areas where the
marketplace is providing solutions, and there is not national standards. I’m
not sure that there has to be.

There is pragmatic solutions that are evolving to meet needs. I am thinking
especially in the e-prescribing area. As we are starting to look at what is
happening in e-prescribing, There are a lot of functions that are being met.
I’m not entirely sure that it is worthwhile to spend the energy, the time, or
put the constraints on the marketplace to impose national standards where the
market is working, people are getting the information that they need in a
certain way.

So I think we may be further along in some areas than we think, if we just
look at what is working, and have some appreciation for that, and not think we
have to have everything standardized.

That is not in opposition to interoperability, and that is my third
observation. I think a lot of folks have come to us saying that the health care
community really needs help with improving interoperability. They have
identified the need for conformance testing, but I don’t think that the answer
of how to do that is simple or obvious. I think that is in part why they have
come to us.

Let me just give the dimensions of that. I am going to suggest that we have
conformance testing as an issue that might be on our agenda, the NCVHS NHII
work group, as an agenda, because I think this may be a good role for us.

One of the things is that the conformance tests need to be developed
quickly. So we have to look at an entity that can develop them quickly, that
can develop them accurately and comprehensively. So this is not just an entity
that I think we can pick off the shelf in terms of a lot of existing entities.
There are very few organizations that are structured to be able to move
quickly. We don’t want conformance to hold up the progress of implementing EHR
systems and interoperability.

The next aspect of this is, they can’t be small. They have got to be big
enough that if they observe that there is a large entity in our health care
delivery system that is not conforming, they are big enough and they are
authoritative enough to be able to publicly indicate that a big entity is
failing to conform with the interoperability standards for the NHII. For that
reason, a lot of people are winding up saying a public-private consortium of
some kind.

In short, these are some really difficult issues. I think the industry
needs our help on this, and I think this is a good item to be on our agenda.

DR. LUMPKIN: Jeff, just so I understand issues raised earlier about
certification of EHRs, would you say that what you are recommending as your
third point would be consistent with that? Would it be larger than just
certification? I am just trying to think of a taxonomy that would get us to the
point of making a decision.

MR. BLAIR: Yes. It is defining the entity and the mechanisms that need to
be put in place to provide conformance testing that is quick and fast and
inexpensive and/or free, and that is authoritative enough so that somebody
can’t ignore the compliance decrees that that entity sets forth.

DR. LUMPKIN: Kelly. Since we didn’t introduce you, Kelly is frequently a
participant with our committee from — what organization do you work with?

MS. CRONIN: HHS. We have formerly or I guess still the application of
health IT, but now officially part of this new office of the national
coordinator.

I just wanted to first point out the need to continue an ongoing dialogue
with the new office, since a lot of what is being addressed by this committee
we are actively working on, and have been losing a lot of sleep over the last
six weeks. For example, the governance and function processes around
certification, that is something that is being actively discussed by various
stakeholders. So far, people from HHS have been facilitating and sitting on the
sideline, not being an active player. But there is already a lot of activity in
that area.

We have been spending probably four or five months, an awfully lot of time
in the last four or five months, looking at a variety of options around
financial incentives, and also non-economic incentives. There is so much time
and effort being spent right now on these issues, I think it is important for
the committee’s work to be focused and to be informing HHS efforts in general
in areas where it is most needed, particularly where we need public input. We
will likely be spending the next two months doing a lot of analysis around the
options that were laid out in the report for incentives, and then moving
forward with some of them hopefully in the near future.

There is also a national alliance for the advancement of health IT that was
mentioned in the report, which will be serving as a mechanism to coordinate
across private and public purchasers and payors, to figure out how everyone is
going to actually move forward in implementing pay for use and pay for
performance.

I think it is important for everyone to know everything that is going on.
Perhaps we could have some kind of mechanism put in place, either for John
Lumpkin or someone else, other members of this group, to be constantly updated
on what is happening.

One last comment. I thought all the comments around secondary uses was very
helpful and very consistent with what we have been thinking about in terms of
the goal of improving population health. One thing that we really do need to be
mindful of is what current statutory authority will allow us to do moving
forward. I think mapping the vision for the future of health statistics with
what regional health information organizations can do in the electronic health
record and the PHR will be very helpful, but we should do it being very mindful
of our current legal framework and how that might need to evolve, so that as
Congress is considering various legislative options, that they are well
informed on what is needed.

DR. LUMPKIN: Thank you. I have two other people on the list, and then I am
going to try to see if we can figure out a way to reach some conclusions. As
all of you know, I am a stickler on ending on time, and we are scheduled to end
at 3:30. So with that, Steve.

DR. STEINDEL: John, I would like to just reiterate, we heard a very
specific recommendation today about a charge specifically to NCVHS about
identifiers. I have to admit, when I sat in the audience, I heard it, I
immediately had the usual NCVHS block that we can’t talk about identifiers. But
if we actually look at the question that they are posing, I view it as not
involving the block. It is involving giving industry guidance on how people
should be identified in the future world.

We have heard around the table today from people who think this is
extremely important to do. We heard it from multiple people at this conference,
that this is an important thing to do. I actually think that it is something
that we could probably do as a work group within the next six months in the
time frame that they asked from us. That might be a good thing to put on the
table as a work product to deliver.

DR. LUMPKIN: Kevin.

DR. VIGILANTE: Were you suggesting that you are agreeing with Bill that we
should not look at the incentive issues? If so, I will cease and desist.

MS. CRONIN: I was completely validating what Bill said before. I guess it
is also important to be mindful of the charter of NCVHS as well. While it is
fundamental that we get these incentives right, and everyone realizes how
important it is, I think the economic incentives at least may not be completely
consistent with the scope of the charter as it is drafted right now.

DR. VIGILANTE: So getting testimony from say the leading members of the
Leapfrog group, whether it is GM or GE, and talking to payors, United and Blue
Cross, and having them talk to us about what are the necessary and sufficient
conditions under which they would provide financial incentives is something
that you are going to tackle, or we shouldn’t tackle?

MS. CRONIN: I think in many ways I have already tackled that. I think to
continue with next steps is within this new alliance that has been formed to
have them engage additional large purchasers and payors. AHIP is now engaged,
and Office of Personal Management is engaged, as is CMS.

So I think the need is to coordinate across those organizations to continue
the dialogue and figure out how they are going to align all the efforts moving
forward. Not to say that everyone has figured out how to design the perfect
program where you will both pay for use and pay for performance. We are a long
way off, and we need to build the evidence base before we make any fundamental
changes to policy. But I think that there is a lot that is ongoing, and I don’t
know that it would be the best way for you all to spend your time.

DR. VIGILANTE: Thanks. Maybe at the very least we could get the outputs for
that at a certain point. I was not aware that those conversations were going
on, and that we had actual information regarding large employer willingness to
pony up.

MS. CRONIN: Yes, I think it has been building over time. And really, this
alliance just got together over the last two weeks. It has been very fast.

DR. VIGILANTE: Thank you.

DR. LUMPKIN: I think we need to wrap up this portion. I see one person at
the microphone. I will call on you, and then we will move on.

MS. MOLINA: I just want to reinforce something that I think might be
helpful for the private sector as we are trying to assist this group and HHS in
addressing these NHII issues.

First, I want to applaud the committee. I have read the reports that in my
view were the foundation for what happened today. I think there are brilliant
minds and wonderful motives that are around this table that have led to this.
So I think that is terrific.

I know that for our own organization, the key barrier to our being able to
serve the market effectively has been a lack of rules of the road. We have been
very challenged in identifying who is in charge of decision making around
standards, what the criteria are, what the process is, what the time frame is,
and essentially what levels of proof or capability we have had to demonstrate
to try to get into the world, in our case, the world of standards, and have
groups that have already acknowledged the need for them be able to adopt them.

What has happened in the marketplace is, individuals who want these
solutions are holding back from full-scale adoption because they are waiting
for the word from the government. I know that there is a lot to be addressed
here, and I think simply the rules of the road would be wonderful in helping
the private sector be able to serve these really important needs.

Agenda Item: Discussion of Work Group’s Next
Steps

DR. LUMPKIN: Thank you. At this time, I am going to make a couple of
general comments, and then see if we can focus our efforts.

First is the role of the committee, what this work group has done, and in
fact, what the full committee has done. I think that in many ways, as we have
looked at our partnership with the Department that we are charged to advise, we
in some ways will get specific charges from the Department, an issue that they
are very interested in and will ask the full committee to look at.

Actually, I think CHI came up that way, not that we weren’t interested,
because we first had a hearing on CHI. Subsequently they said, we were trying
to go through with these 24 dimensions, and we need help from the committee in
trying to vet these, so that subsequently we can adopt them.

Once the Department adopted those recommendations, pretty much our work was
done. Sometimes a few months went by, sometimes a few years went by. It
certainly happened with the HIPAA recommendations. But I don’t think we felt
the need to get involved in the implementation process.

The other way that we have been useful, I believe, to the Department is
identifying areas where we don’t think there is enough attention being paid.
The NHII is an example. All the discussions about the next generation Internet,
where we thought that the Department ought to be playing more of a rule in some
of these high-level committees within the U.S. government, and we made
recommendations. And there have been others.

I set that as a background. As I look through this list, there are things
that I personally would like to do a lot of discussion about. But the truth of
the matter is, there are many things where the train is already out of the
station, and the Department has already gotten the message. Given our time and
our commitment, where is it that we can add value. I think that would be the
criteria.

One criterion that is important is the issue, and the second is, can we add
to the debate. Then the third criteria would be, if we don’t do it, who is,
because no one else is.

Let me use as an example, we had a fair bit of discussion about incentives.
What we have heard today are a couple of things. We have heard that that is an
issue that Connecting for Health is addressing. They are making
recommendations. In the broader arena of incentives for quality, as Jeff
raised, we know that Leapfrog is deeply involved with that. My organization is
funding a couple of million dollars in grants. There are things that are
actually happening in that area, as well as the fact that this is something
that the office of the national coordinator has identified.

I’m not sure that we can add value to that, even though it would be
interesting to conduct the hearings. Considering the time frames in which the
office of the national coordinator is operating, I’m sure by the time we come
up with a recommendation, it would be less than helpful.

So having discussed that, there is one issue I am going to put on the list,
and then we are going to try to work to one down the list over the next 15 or
20 minutes. That is a synthesis of all the discussion. That is a research
agenda for the National Health Information Infrastructure. There are a lot of
issues — and this came up under incentives and other areas — where we said,
we just don’t know, and we ought to know.

There may be a value for us to spend some time and conduct hearings, where
we actually say, what are the areas that we ought to make recommendations to
the Department, through the office of the national coordinator or NIH or other
areas, where research ought to be done in the near term, so that we can
actually make some intelligent choices.

So having thrown out that new area, let me run through the list of what my
notes say we have as proposed candidates for activities by the committee.

The first item I have on the list is research, but it is not the research I
just talked about, because that is last on the list. That is, the interface of
research with data collection, population health and other areas.

Second was the personal health record and the personal health dimension.
Third is population health, to what extent are standards being developed there.
Fourth are incentives. fifth is looking at interoperability issues. I’m going
to stop counting, because I don’t have numbers on my paper. Legal obstacles for
implementation. The issue of certification and reference for implementation; I
think we can combine those. The interaction between quality and electronic
health records. Public health, which I think we can roll into population
health. Secondary uses of the electronic health record generating things in
both research and population health as well as quality. Rules of the road that
Steve talked about. Revisiting the 21st century health statistics report that
we had, and looking at how that interacts with the development of the NHII.
Movement of data from one dimension to another, which I saw as a summary topic
for some of the interactions. That may actually be the same thing as secondary
uses.

A term that Steve brought up, the patient ID, which I will roll into the
concept of not just the patient ID, but how people are identified within the
National Health Information Infrastructure. The research agenda for the NHII.
Metrics, which was raised today, in other words, how do we measure how the NHII
is being implemented. Then confidentiality and options.

Did I miss anything? Let’s go through the list one more time. What I want
to do is do an iterative process and see if we can take anything off the table.

Research. Do we want to take it off the table? Jeff, you are shaking your
head, or you are nodding?

MR. BLAIR: I’m going to abstain.

DR. LUMPKIN: Okay. Anybody want to take research off the table? We will
come back to it again.

DR. COHN: So we raise our hands if we want to take it off the table?

DR. LUMPKIN: Yes, if you want to take it off the table, raise your hand.

PARTICIPANT: This is not the research agenda?

DR. LUMPKIN: This is not the research agenda. This is research and the
National Health Information Infrastructure.

DR. STEINDEL: Can you say you are assuming it is subsumed into something
like secondary uses?

DR. LUMPKIN: Taking it off the table or combining it in another area.

DR. STEINDEL: I don’t want it taken off the table, but I think it is
combined with secondary uses.

MR. BLAIR: That is the reason I started to abstain. When I started to
combine it mentally with secondary uses, I thought, well, maybe we need to keep
it on.

DR. LUMPKIN: So I am going to put together research, secondary uses and
movement of data from one dimension to another.

DR. COHN: And probably quality.

DR. LUMPKIN: And quality.

PARTICIPANT: What about population health?

DR. LUMPKIN: Okay, and population and public health. So the general title
that I will put on this is movement of data between the dimensions — that is a
bad title, but that describes stuff moving —

DR. COHN: Why not call it secondary uses?

DR. LUMPKIN: Okay, secondary uses. Personal health record. No one wants to
take that off the table. Incentives. We have got some votes to take it off the
table, it is gone.

DR. STEINDEL: Go back up to the personal health dimension. Is this
something that is going to be overtaken by events? Things are moving rapidly in
that area. I don’t want to take it off the table. I’m just wondering. I’d like
a comment from other people who are closer.

DR. LUMPKIN: Let me suggest then that we have another category, which is,
we will leave it on the table but we will revisit whether or not we want to
come back to it. So if we were to look at this in another six months, we can
say, has enough happened that we are comfortable that it is moving.

DR. STEINDEL: I’m not comfortable with taking it off the table. I am
comfortable with parking it for a minute.

DR. LUMPKIN: Parking it?

DR. STEINDEL: Yes.

DR. LUMPKIN: So we have got a park for personal health record.

MS. CRONIN: Can I just add to that? I think it is probably an area that HHS
has spent the least amount of time on, and requires a lot of attention to
develop. I don’t know that at least in the office of the national coordinator
that we have rich resources to devote to it right now, although it will be a
priority. Just food for thought.

DR. LUMPKIN: So is that a park?

MS. CRONIN: No, no, that is a keep it on.

DR. LUMPKIN: Keep it on, okay.

DR. STEINDEL: That is the sense I need. We heard from Dave Lansky, and I
know there is movement forward in the area. I just don’t know how rapid it is
moving.

DR. LUMPKIN: I just happened to get an e-mail from Cynthia Bower, who is
listening on the Internet, so I am embarrassing her. She is working on
something looking at the federal role in relationship to personal health
records. That is something that potentially could be the subject of a hearing
this fall, that would help the development of that work, working with Susan
Connaught. So let’s keep it on the table?

DR. STEINDEL: Let’s keep it on the table. I was asking for information, and
I got it.

DR. LUMPKIN: Thank you for stopping me. Interoperability issues?

DR. YASNOFF: Can we combine those things into the rules of the road
category?

DR. LUMPKIN: Okay, interoperability, rules of the road, what else?

DR. YASNOFF: There are legal issues and certification.

DR. LUMPKIN: Legal obstacles, certification.

DR. YASNOFF: And there may be one other thing.

MR. BLAIR: I feel as if certification is a big thorny issue. Although I
think logically it could be combined, I think it ought to be a separate agenda
with a separate focus.

DR. LUMPKIN: The issue is that Jeff thinks it is too big to put in the
envelope, let’s leave it out for right now. Anything else that we want to put
in the envelope of rules for the road? if we see something else as I go down
the list, then we can add it.

Public health we put into the secondary uses. 21st century health
statistics?

DR. STEINDEL: I believe that is secondary uses.

DR. LUMPKIN: Secondary uses.

DR. GREENBERG: Only partly. You wouldn’t make it a separate thing. I was
just commenting about the certification one. Yes, of course it is a big thing
by itself, but it really fits in with where we wanted to group it. If you look
at the first one, you’ve got research, population health, public health, what
else did you put in there, quality. So that is a biggie also. It is just how
you want to slice and dice.

But I would say certainly 21st century goes where population health does.
I’m not crazy about the — if you are talking about secondary uses of the EHR,
because otherwise some of it is primary data and the NHII, that isn’t from the
EHR. That is why I don’t like a umbrella term of secondary uses.

DR. LUMPKIN: Actually, as I understand what we said by secondary uses, it
is the use of data outside of where it is collected. So for instance, if there
is data collected in the population health dimension and it is used in the
personal health record or it is used in the electronic health record,
environmental data, all sorts of things, that would be a secondary use.

DR. GREENBERG: But you said moving data between dimensions is really what
you are talking about, without prejudging where it starts.

DR. LUMPKIN: Right.

DR. STEUERLE: John, maybe it is just me, but sometimes I am having trouble
knowing whether you are talking about things related only to NHII, or you are
talking about things broadly for the committee as a whole, regardless of
whether it is NHII. You might just be clear when you bring up these topics.

DR. LUMPKIN: No, we are talking about the work for this work group. So for
instance, —

DR. STEUERLE: When you say population health —

DR. LUMPKIN: That would be the population health dimension.

DR. STEUERLE: Of?

DR. LUMPKIN: Of the NHII. That would not be the more specific targeted work
that is being done by the population subcommittee. If there is something —
like for instance, a lot of the confidentiality issues, I would argue, ought to
be in the privacy committee, because that is what they do, or subcommittee.

So the question on the table is the 21st century, and it is in.

DR. STEINDEL: I would just like to make a comment to Kelly that if the
office hasn’t really visited that report, and I’m sure you have had a lot of
spare time to visit that report in the last few weeks, it does touch on some of
the issues that you talked about, legal, et cetera, what laws need to be
changed as we move into the modern age, et cetera.

DR. LUMPKIN: How people are identified in the National Health Information
Infrastructure.

DR. YASNOFF: That is really developing a standard mechanism for patient
identification. That is what I understood we were saying.

DR. LUMPKIN: Yes.

DR. YASNOFF: I think we should refer that to the Subcommittee on Standards
and Security.

DR. LUMPKIN: My only comment on this, because Simon tried to sell it to me
before, I just had to remind him that the last time this committee addressed
this issue —

DR. COHN: But Dr. Lumpkin was the chair at that point of the activity. I
thought for continuity’s sake that we should continue that.

DR. YASNOFF: We are not talking about a discussion of the unique patient
identifier. We are talking about a standard mechanism for identification. I
think again, it seems to me that this is very much a matter of agreement where
taking testimony from a number of groups and synthesizing it might not even
come up with a solution, but might be very helpful in moving things forward.

DR. STEINDEL: If I could make a comment with regard to our spare time, et
cetera, we actually have this as part of our e-prescribing agenda for after the
first stage, patient identifiers.

DR. COHN: But this is not patient identifiers.

DR. STEINDEL: I know, but we can slip this in as part of that.

DR. COHN: This is a different topic. I want you to be very clear about
that.

DR. STEINDEL: We can put it into that hearing time.

DR. YASNOFF: It certainly would be valuable for e-prescribing to be able to
identify patients.

DR. LUMPKIN: We are going to move on. The research agenda for the NHII?

PARTICIPANT: Go for it.

DR. LUMPKIN: Go for it, okay. Metrics for the NHII? Bill?

DR. YASNOFF: If you will recall, we had some discussion in the work group
before, I brought some material in. I think again, the issue of metrics may not
be the ideal issue to deal with in the context of taking testimony about what
it should be and synthesizing it.

DR. LUMPKIN: Off the table?

DR. YASNOFF: Yes, that is essentially what I am suggesting. I’m not saying
it is not important. It is very important.

DR. LUMPKIN: Well, the question is, do we want to put this in the same
place that we were going to put personal health record, until we decided not
to?

DR. YASNOFF: Yes.

DR. LUMPKIN: On the shelf?

DR. YASNOFF: Yes.

DR. LUMPKIN: Revisit it in six months?

DR. YASNOFF: Yes.

DR. LUMPKIN: Marjorie.

DR. GREENBERG: The only thing about the whole metrics issue is that the
committee is required to report to Congress on the implementation of HIPAA.
That is primarily the administrative transactions and the privacy.

We have bounced back and forth the need for metrics. Somebody raised it
today, as to what the impact of the privacy is, and haven’t really been able to
take that very well forward. But HIPAA does include the PMRI, et cetera. Up
until now, when we report to Congress on an annual basis, we have reported on
what we have been doing from the point of view of standards development and
recommendations for PMRI. So I’m not sure you can avoid that issue of metrics.

DR. COHN: I’m sorry, Marjorie, I don’t mean to break in, but I don’t think
we should avoid it, but I don’t think it is a first priority item. I think
revisiting it might be appropriate.

DR. GREENBERG: It is just that we have been spending several years now
recommending standards, and I think it is part of the charge of the committee
to say to what extent are the standards being actually adopted, and what is the
impact of them.

DR. LUMPKIN: Bill

DR. YASNOFF: The work group has already committed to monitoring the
progress of the NHII. So this isn’t an issue we can discard. I suspect that
there will be a number of proposals in the next few months, perhaps from the
Department, perhaps from other sources, as to how to monitor this, and when
those come up, we should pay attention to them. But again, I don’t think it is
the most urgent issue.

DR. LUMPKIN: Steve.

DR. STEINDEL: I would like to answer the question that Gene asked awhile
ago, are there any good metrics in this area. That is, no.

DR. GREENBERG: You don’t need hearings. You can tell us.

DR. STEINDEL: I actually can, because basically one of the metrics that is
out there is the survey that we did through the NHII work group. While it is a
very interesting and informative survey, it is not a good metric. That is the
way most of the information about the NHII looks today.

The problem is, this work group can’t go out and do metrics. The metrics
that we rely on for monitoring HIPAA come from other sources. As Bill just
pointed out, those other sources, we are now starting to realize they are
needed, and they are going to come on board. As they come on board, we should
start looking at them. So I agree with the parking.

MS. CRONIN: Just one additional brief comment. We had actually talked quite
a bit about metrics over the last month, and had been in various drafts of the
report, but didn’t think they were thoroughly thought through. Obviously there
was not enough time, and we didn’t get any other input.

In the report it does specify in terms of implementing actions that are
laid out in the framework that we will be monitoring progress and setting
specific metrics that are measurable. Then we will have a data strategy around
each one of those that we define.

I don’t know if it was mentioned on Monday or not, but AHRQ is going to be
doing a survey through the definitive HIT adoption survey, either annually or
biannually, to be doing a very careful measurement of the actual uptake of EHRs
in different IHT products. It is quite possible that we could be adding on
different measures to that as well. NAMSES and HAMSES also have some questions
built into it.

So there is a lot of thinking going on in this area. I’d like to also
reiterate what Bill said. I think it would be probably problematic to get a
huge amount of public input, and do this either through the committee or
through another organization that I think was recommended earlier this morning.

DR. LUMPKIN: Given that, here is what I sort of take away, and see if we
are all there. I see that there are three items that are on the list. One is
how people should be identified that we are going to try to turf to Standards
and Security.

DR. COHN: We will accept it, John, thank you.

DR. LUMPKIN: The confidentiality — and for those of us who are physicians
and have been residents, you know how important it is, no matter how
interesting the patient is, when you are being hit hard, you always try to find
other places to send the patients. So this is medicine saying to surgery that
it is probably your patient.

Privacy, the areas of confidentiality and other options, I think we need to
look to the Privacy Subcommittee to look at that.

The issue of metrics we are going to put on the shelf, we are going to
revisit it in six months and see what progress has been made, and whether or
not there is any role for us.

That leaves us with four topics. The four topics I see as a summary of this
discussion are, one is secondary uses, two are rules of the road, three is
research agenda, and four is the personal health record. I think that given
that Cynthia is already working on this, we potentially can look at having a
hearing on that, particularly in relationship to the federal role in developing
that in the fall.

We would of course bring all this to the executive subcommittee, but one of
the things I would ask Steve to take a lead on is to maybe put a little thought
into pulling together the concept of the rules of the road and how we would
tackle that.

DR. STEINDEL: Certainly, John.

DR. LUMPKIN: Then we can bring that for a discussion at our meeting in
September. Likewise with the secondary uses, perhaps we can get a volunteer for
someone to think about that and pull that together.

MR. BLAIR: John, a couple of us down at the end here didn’t hear
conformance testing and certification. Where did that go?

DR. LUMPKIN: I thought we had pulled those into rules of the road.

MR. BLAIR: See, I had thought it was going to be too big.

DR. LUMPKIN: Jeff, you are correct. Conformance testing, I would argue for
putting that on the shelf, because that was a big part of what Connecting for
Health talked about. I believe that David Brailer talked about that. This may
be something that we may just want to revisit to see if we are comfortable with
the progress, rather than necessarily trying to get involved in the details of
its rollout, if that is okay.

MS. CRONIN: I would just support that, because that has been one of our
primary focuses over the last several weeks. I think it is largely being
handled right now by various groups in the private sector, but if that fails,
then there is going to be a real need to figure out alternative options
quickly.

DR. LUMPKIN: The last item is the research agenda. My guess is that in our
meeting in September, we can begin to talk about how we would conduct hearings.

So based upon this, the goal was to try to put together a hearing in the
fall on the issue of the personal health record, and that in our September
meeting we will talk in more detail, trying to sketch out a work plan related
to secondary uses, rules of the road, and we can also begin to work out a
schedule, probably a hearing in the early part of ’05 related to the research
agenda for the NHII.

DR. COHN: Let me make a comment about the research agenda. AHRQ is actually
taking a major leadership role. They actually had a meeting last week that
focused on that. We may want to get AHRQ to come in early on, get them in just
to give us a briefing on what their plans are.

DR. LUMPKIN: We can maybe consider that to be a shelf and look at that —

DR. COHN: Yes, or an hour briefing during our next meeting.

DR. LUMPKIN: Mary Jo.

DR. DEERING: My only observation about that and this thing about the
metrics that Kelly talked about is, I guess I can say I would bet my next child
that you are probably looking at EHRs exclusively, and health care metrics and
the research agenda in the health care delivery area. To the extent that you
have population health or the personal health or these other concerns, those
will probably be gaps.

So just bear in mind that that might be something that you would appreciate
us looking at and taking that on, to the extent that there is already at least
some work underway in the clinical side. I don’t know.

MS. CRONIN: I think in terms of what I know AHRQ has been talking about, it
is more focused on health care, absolutely. But for the strategic framework,
population health has a variety of activities within it. We certainly do have
intentions to develop careful metrics and make sure we have definitive ways to
measure all of that over time.

So from that perspective, we will be trying to cover it. But that is not to
say that we are going to get it right over the next 60 days. It is going to be
something that we will have to work with the various agencies with.

DR. LUMPKIN: With that, I think our job is done. Thank you very much.

(Whereupon, the meeting was adjourned at 3:33 p.m.)_